Careers

Working Together Toward a Shared Vision

At Allena, we’re proud of our dynamic, thoughtful and engaging culture, and we are always looking for outstanding professionals to join our team.

We are innovators and collaborators. We fully appreciate our responsibility to the patients and to our stakeholder community, which is supporting our efforts to advance the development of novel oral enzyme therapeutics to treat complex metabolic complications.

Allena is currently seeking to fill the following positions. To be considered for a position, please complete the form below and send us your resume. 

Senior Director, Clinical Research/Clinical Development

JOB DESCRIPTION: 

Reports to and works closely with VP of Clinical Development. Responsible for implementing the global Phase III program for the lead compound in close partnership with Clinical Operations. The Senior Director will engage and establish relationships with the medical and patient communities to inform and execute the Phase III Program, while ensuring strategic alignment of internal and external activities. With other relevant Allena functions, will also contribute to developing the strategy for development of follow-on compounds. This position works collaboratively with other Allena functions including Medical Affairs, Commercial, and Regulatory Affairs. 

Responsibilities: 

  • Serve as primary Medical / Scientific leader for the reloxaliase (formerly ALLN-177) program. In that capacity:
    • Develop and implement medical / scientific strategy through strong engagement and learning from medical/KOL and patient communities 
    • Participate in site identification and PI engagement, Investigator’s meetings, working closely with clinical operations personnel, CRO, etc. 
    • Contribute to development of Phase III study-related documents and statistical analysis plans 
    • Partner closely with Clinical Operations to proactively identify program risks, and create and implement mitigation strategies 
    • Oversee and participate in ongoing safety monitoring and the interpretation/analysis of trial results including laboratory and biomarker data, review and approve trial coding. 
  • Oversee and contribute medical/scientific input to the preparation of clinical study reports, Investigational Brochures, statistical analysis plans including the ISS and ISE, periodic safety update reports, briefing documents, annual reports, IND, BLA and other regulatory documents 
  • Collaborate cross-functionally in strategic planning and contribute to preparation of the clinical development plan (CDP), product development plan, target product profile (TPP) and other corporate documents 
  • Handle day-to-day medical and scientific questions from various internal and external sources 
  • Analyze and interpret data, and clearly communicate results both internally and externally, through presentations, publications and education material 
  • Participate in preparation for and in meetings with the EMA, FDA, or other regulatory bodies 
  • Mentor junior team members 

Qualifications: 

  • MD is required, specialty in internal medicine or relevant subspecialty (nephrology or rheumatology, endocrinology ) or urology preferred, and /or significant experience in nephrology/ urology or related indications; minimum 5 years of pharmaceutical clinical research or other highly relevant clinical research experience (e.g., academic research) 
  • Knowledge of scientific principles of controlled clinical studies, and working knowledge of GCP and FDA/ICH guidelines 
  • Demonstrated experience in clinical research and ability to meaningfully contribute to development strategy, critical review of data, generation of research hypotheses, publication and presentation of scientific information 
  • Exemplary written, verbal and electronic communications skills with diverse audiences 
  • Proven success working with and effectively supporting cross-functional teams 
  • Professionalism, objectiveness, critical thinking, evidence-based reasoning, and a positive outlook are essential 
  • Ability to travel up to 20-25% of the time 

Allena Pharmaceuticals is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Clinical Trial Associate

JOB DESCRIPTION: 

The Clinical Trial Associate (CTA) is responsible for assisting with execution of clinical trials while ensuring the trial is conducted in compliance with the protocol, ICH/GCP, applicable regulatory requirements and applicable SOPs/Work Instructions. The CTA is an in-house position. Responsible for assisting and providing support to the members of the clinical operations project team in order to facilitate the management clinical trial processes including planning, execution and closeout of outsourced clinical trials. The Clinical Trial Associate assists in the supporting the conduct of trials and may be responsible for managing specific study and operational tasks and hold vendor management responsibilities. 

RESPONSIBILITIES: 

  • Facilitate CDA & clinical trial agreement execution process and participates in site selection and startup activities 
  • Participate in creation and distribution of sponsor specific study aides/materials and communications 
  • Assists with the generation of study specific documents including protocols, study plans, and templates 
  • Review of clinical documents, ICFs, essential documents/IMP release packets 
  • Review and provide tracking oversight of Monitoring reports 
  • Support the development and design of CRFs, including participating in the EDC and IXRS specification process and UAT 
  • Under supervision of study manager or clinical lead, may assist with tasks typically associated with study management such as manage study vendor 
  • Liaise with Regulatory to support Clintrials.gov updates 
  • Responsible for agenda and minutes distribution for internal study team meetings 
  • Review of Trial Master Files 
  • Participate in data reviews 
  • Support invoice and budget activities 
  • Contribute to preparation of presentations 
  • Maintain up-to-date internal/external training as necessary 
  • May participate in site visits 
  • Performs other work-related duties as assigned 

REQUIREMENTS: 

  • Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH/GCP guidelines, is required 
  • Associates/Bachelor's degree and/or equivalent relative experience required 
  • Minimum 3-5 year's experience in supporting or managing tasks within a pharmaceutical/biotech or CRO setting. 
  • Strong interpersonal, organizational and multi-tasking skills; attention to detail 
  • Displays initiative and a maintains a solutions approach 
  • Adaptable to changing priorities, excels in fast-paced environment 
  • Perform job duties with minimal supervision and guidance 
  • Occasional Travel may be required (eg, 10%) 
  • Prior CTA or CRA (monitoring) experience preferred 

Allena Pharmaceuticals, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Quality Control Manager

JOB DESCRIPTION: 

The QC Manager, reporting to the Sr. Director of Quality Control and Stability, will manage the day-to-day QC including method transfer, qualification, and validation, managing the testing activities at external contract laboratories, Assay Life Cycle management, Critical Materials management, and data review. This is an opportunity for the right individual to join the Allena team at a time where significant growth is occurring and the development of a scalable quality unit is key. He or she will help develop processes and procedures that reflect best practice and provide assurance that the products Allena releases to the clinic and future commercial market meet Allena’s high quality standards and FDA regulations. A high level of initiative, competence and professionalism is a key requirement. This role works across multiple departments, including Quality Assurance, Analytical Development, Supply Chain, Manufacturing, and Regulatory. 

Responsibilities: 

  • Support all QC functions related to GXP activities including authoring sops, protocols and reports supporting testing and method transfer and validation. 
  • Responsible for the management and monitoring of the progress of all QC testing activity and deliverables at CMOs and CTLs (including in-process, release and stability) and ensures complete documentation for compliance with cGMPs. 
  • Review release and stability data and provide feedback to both external and internal teams. Approve certificates of analysis received from contract laboratories. 
  • Author and review method transfer/qualification/validation protocols and reports 
  • Provide technical support for internal and external investigations, deviations, CC and CAPA activities. 
  • Perform trend analysis of testing data to establish release specifications for in-process and finished product 
  • Assist with preparation and review of IND and BLA submissions 
  • Assist the preparation, review and approval of Annual Reports 
  • Technical writing is critical as the candidate will be required to write new standard operating procedures (SOPs), protocols, reports, deviations and memos. 
  • The candidate will play key roles in all method transfers and validations. 
  • Support long-term planning of all QC lab capabilities and capacity. 
  • Responsible for coordinating with AD for the implementation of new technologies into the CTL network. 
  • The candidate must be able to troubleshoot issues and must work well in a team environment and be able to work across multiple departments. 
  • Assist in continuous improvement activities 

Qualifications: 

  • B.S/M.S. in life sciences, preferably Chemistry, with minimum of 5-10 years pharma/biotech QC experience 
  • A minimum of five years of hands-on QC laboratory experience in a GMP laboratory setting. 
  • Demonstrate conceptual and theoretical knowledge in chemical analysis methodologies, including methods common for biologics analysis including RP-HPLC, SEC-HPLC, SDS-PAGE, ELISA, Dissolution, in addition to compendial testing. 
  • Solid understanding of cGMP requirements and thorough knowledge of ICH method transfer and validations requirements. 
  • A comprehensive understanding of a Quality Control environment and GxP procedures is required. 
  • Experience reviewing and approving raw data, test results and Certificates of Analysis for raw materials, drug product intermediates and final product. 
  • Experience authoring, reviewing and approving method transfer and method validation protocols and reports 
  • A minimum of three years of experience working in companies that have an outsourced/ virtual business model 
  • Proven ability to work independently and effectively handle multiple priorities is a must. 
  • Excellent interpersonal skills, strong organizational skills and effective communication across all levels within an organization. 
  • Effective problem-solving skills and results orientated. 
  • Strong computer skills including knowledge of Empower, JMP, Excel, PowerPoint. 
  • The flexibility to travel to Allena’s contract laboratories when required. 

Allena Pharmaceuticals is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Director/Associate Director, Medical Affairs

JOB DESCRIPTION: 

Allena Pharmaceuticals is recruiting for a professional with experience in conducting high level scientific and strategic interactions with external thought leaders and internal stakeholders, to join our team based in Newton MA. Reporting to the Vice President of Clinical Development, the Medical Affairs Associate Director/Director will provide strategic input to all medical affairs initiatives. S/he will be responsible for managing medical affairs activities including oversight of non-registrational studies, supporting clinical trial recruitment, developing and nurturing opinion leader relationships, helping to plan the medical affairs organization and managing data dissemination for reloxaliase (formerly ALLN-177), including publications, congress planning, and implementation of scientific communications. 

We are seeking a highly motivated individual who can work independently on a broad range of projects and will collaborate effectively with individuals across multiple functions including Clinical Research/Development, Clinical Operations, Business Development, Strategy and Commercial. 

Responsibilities: 

  • Scope out Allena medical affairs priorities and define medical affairs plans, gaining cross-functional input from clinical, regulatory, legal, commercial, etc. 
  • Develop compliant relationships with thought leaders and investigators, and cultivate partnerships with Advocacy Groups and other organizations. 
  • Support PI engagement and recruitment of Phase III studies, working closely with Clinical Development and Clinical Operations 
  • Plan and provide medical oversight of other Sponsored studies (e.g., Phase I, phase IV, registry, expanded access) 
  • Develop a deep scientific knowledge base of Allena products and their target disease states, and a solid understanding of the relevant physician communities and their practice patterns 
  • Keep abreast of scientific, disease state, emerging therapies and healthcare landscape information in order to provide medical leadership and insights to all Allena activities, collaborating cross-functionally 
  • Identify and engage with KOLs and other critical clinical stakeholders, harnessing critical insights and ensuring cross-functional alignment and coordination. 
  • Plan and participate in scientific meetings and conferences; synthesize scientific insights and communicate feedback gathered from scientific exchange to support medical affairs strategies 
  • Oversee and lead development of publication and congress plans that optimizes data dissemination for reloxaliase and other Allena pipeline assets. 
  • Lead the development and review of abstracts, oral presentations and other scientific publications for Allena assets, ensuring consistency of content and scientific messages across all communications. 
  • Handle day-to-day medical, and scientific questions from internal and external sources, and lead preparation of responses to medical information queries 
  • Identify, facilitate and track progress of data generation activities through investigator-initiated research (IIR) Studies 
  • Develop, plan and provide support for medical education activities, such as advisory boards, congress symposia, steering committees and stakeholder meetings. 
  • Maintains cross-functional collaboration with internal functions & field teams to provide scientific expertise and advisement to Clinical Research, Clinical Operations, Product Teams, Commercial, Corporate communications, etc. 
  • Actively participate in the development and oversight of the field based MSL team. 
  • Travel up to 50%, including overnight and weekend commitments. 

Qualifications: 

  • MD, PharmD, PhD or other advanced medical/scientific degree; experience in nephrology or urology preferred 
  • Minimum 5 years of pharmaceutical/biotech industry experience in related areas (Medical Affairs, Research & Development, Medical Science Liaison); experience with design and oversight of clinical trials a plus Excellent communication and presentation skills both written and verbal 
  • Experience with medical communications and publication planning and development 
  • Strong cross-functional orientation 
  • Excellent interpersonal skills with demonstrated track record and ability to drive results as an effective team member and project leader 
  • Flexibility and ability to adapt to changing conditions 
  • Excellent problem solving, organizational, and negotiating skills 
  • Motivated, self-starter who operates well in a smaller organization and is passionate about building medical affairs capabilities within an organization 

Allena Pharmaceuticals is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Associate Director, Program Management

POSITION SUMMARY: 

We are seeking an energetic leader who thrives in a dynamic, growing, fast-paced, team-oriented and collaborative environment. The ideal candidate will be responsible for leading a cross-functional development team, including CMC, nonclinical, clinical, regulatory, commercial functions. The candidate will play a key role in day-to-day operations and planning, will represent the Program to internal and external constituencies, and will contribute to the Portfolio Steering Committee. Reporting to the VP of Program and Alliance Management, this is a fantastic opportunity to provide leadership in a growing Allena across all aspects of the business. 

ABOUT THE ROLE: 

  • Lead program management activities for a key Allena development program, including planning, reporting, global risk assessment and mitigation, and lessons-learned 
  • Implement and apply consistent Program and Project Management standards, including the use of templates, tools, and processes to drive cross-functional efficiency, alignment, and effective planning and execution 
  • Collaborate with PMs in building team effectiveness, planning, and navigating issues 
  • Proactively identify potential issues and lead contingency planning and problem-solving by applying appropriate analytical tools and techniques 
  • Negotiate with functional heads and/or bring issues to senior management or governance committees to remove roadblocks, when appropriate 
  • Develop and manage project plans inclusive of ensuring control and communication of project budget, scope, schedule, progress, and risks 
  • Partner with functional heads and finance on management, control, and reporting of functional and program budgets 
  • Lead cross-functional program team and related subteam meetings 
  • Facilitate cross-program reporting and presentation of program information to the Functional Heads, Portfolio Steering Committee, and other key stakeholders 
  • Facilitate decision-making, collaboration, and problem-solving with people at all levels of the organization to accomplish shared program goals. 

EXPERIENCE: 

  • B.S., M.S., or Ph.D. in scientific or business discipline (i.e., biology, chemistry, medical technology, or business administration) 
  • PMP Certification or equivalent preferred 
  • 7+ years of professional experience with a minimum of 3 years managing complex cross-functional projects in the pharmaceutical/biotechnology arena. Prior experience with clinical development and CMC/technical operations, highly desirable 
  • Experience managing alliances with external partners and/or service providers including contract research organizations and/or contract manufacturers 
  • Strong knowledge of the drug development process from pre-IND to commercialization and understanding of FDA and ICH guidelines. Additional knowledge of global regulations highly desirable 
  • Demonstrated influence, negotiation, problem-solving, strategic thinking, and conflict resolution skills, including the ability to influence and align without clear reporting authority, are strongly desired 
  • Very strong interpersonal skills to bridge scientific and business participants for negotiating timelines, resources and effective international collaborations 
  • Good oral/written communication skills, allowing effective interactions with all levels of the organization is required 
  • Solid analytical skills for integrating and interpreting interdisciplinary project information. A high degree of organizational awareness and understanding of change management is preferred 
  • Proficient in Project Management systems, tools, and MS Office Suite Software 

Allena Pharmaceuticals, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Associate Scientist

JOB DESCRIPTION: 

The Associate Scientist position requires the individual to have laboratory training and experience to support Analytical Development for oral solid dosage enzymes. This role has a heavy emphasis on HPLC and the individual will be responsible for performing method development and routine analytical assays to support stability, characterization, and in-process testing. The individual will be expected to maintain laboratory notebooks, provide data summaries, and execute lab work independently. Additionally, a qualified candidate should be able to contribute to experimental design for development of HPLC methods. 

RESPONSIBILITIES: 

  • Perform and record analyses as assigned on a daily basis. 
  • Develop and/or review revisions to procedures as needed. 
  • Purchase laboratory supplies as needed. 
  • Coordinate sending samples and receiving data from contract laboratories as needed. 
  • Responsible for completing assigned research projects on time. 
  • Prepare summary reports and/or presentations as necessary. 
  • Accountable to the leader (and rest of department) for ensuring proactive execution of work assignments. 
  • Assist in maintaining a clean, safe workplace on a daily basis. 
  • Additional tasks may be assigned as necessary. 
  • International travel may be required. 
  • Operate chromatographic equipment and data acquisition/analysis software 
  • Demonstrated oral and written communication skills. 
  • Maintain laboratory notebook and records in accordance with laboratory requirements including timely recording of information for review. 
  • Assist with chemistry lab/product investigations and studies. 
  • Ability to function in a chemical laboratory environment; should have no known sensitivities to chemicals present in the laboratory and no health conditions that preclude their working in a chemical laboratory environment. Note that color blindness can be a detriment to performing certain laboratory procedures. 
  • Ability to work hard and contribute to an energetic working environment. 
  • Willingness to learn new things. 
  • Ability to function in a small company atmosphere. 
  • Ability to cope with a rapidly changing work environment. 
  • Ability to multitask. 
  • Commitment to teamwork. 
  • Commitment to continuous improvement in all areas. 
  • Ability to focus attention to details and ensure high quality work. 
  • Ability to work safely; seek out and encourage safe practices. 

REQUIREMENTS: 

  • Bachelor’s or Master’s Degree in Analytical Chemistry, biochemistry or related field. 
  • Requires 4-6 years of relevant experience (or equivalent combination of education and experience). 
  • Must have a minimum of 3 years direct hands on HPLC experience, preferably with method development. 
  • Familiar with proper preparation and use of laboratory solutions (buffers, mobile phases, solvents, etc.). 
  • Basic chemical reactions and equilibria. 
  • Experience or knowledge of the set up and use of spreadsheets for analysis of results. 
  • Basic Statistics (SD, RSD etc.). 
  • In-depth knowledge of HPLC and various column technologies. Experience with Waters and Empower preferred. 
  • Knowledge of other standard analytical techniques such as SDS-PAGE, UV and enzyme assays a plus. 

Allena Pharmaceuticals, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Formulation Development - Consulting/Contract

JOB DESCRIPTION: 

We are seeking a Head of Formulation Development who is interested in joining a highly dynamic and intellectually challenging team. This leadership role will afford a qualified candidate an opportunity to work in an innovative, fast paced environment and shape Allena’s vision to bring new products to patients. Reporting into the Senior Director of Process Development and Manufacturing, the successful candidate will be responsible for establishing and leading Allena’s drug product development strategy. 

RESPONSIBILITIES: 

  • Define and execute overall strategies for drug product development within Allena including collaborating with Preclinical and Clinical Development in the definition and delivery product meeting expectations of the target product profile 
  • Design, create, and help characterize API formulations for Allena’s lead and pipeline oral solid drug candidate products 
  • Determine the contributions and interactions of formulation constituents towards mechanical, chemical, processing, and stability attributes 
  • Prepare and direct formulation and development plans for internal and partnered R&D programs 
  • Lead and oversee all facets of formulation development and drug delivery internally including design of experiments, analysis and reporting of results 
  • Provide scientific support for tech transfer and drug product GMP clinical manufacturing 
  • Responsible for authoring CMC related sections for regulatory filings and development reports 
  • Deliver technological innovation in formulation development and drug delivery 
  • Contribute to internal scientific and strategy discussions to advance product candidates 

QUALIFICATIONS: 

Education: 

  • The successful candidate will have a MS/Ph. D in Engineering, Materials Science, Pharmaceutical Sciences, Pharmacy or related field. 

Experience 

  • Minimum of 10 years of experience in solid dosage formulation. Previous experience with biologics or live bacteria products is a plus. 
  • Substantial experience in supporting drug product development from early clinical to commercial launch. 
  • Recognized as an expert in formulation development, scale-up, tech transfer; and manufacturing support. 
  • Significant technical project management and/or project leadership experience 

Specialized knowledge, Licenses, etc.: 

  • A self-starter and strategic thinker with a demonstrated ability to drive for results and lead innovation. 
  • Proven ability to drive technical strategy as well as lead and influence cross-functional teams. 
  • Successful in developing and broadly communicating cross-functional technical strategy and direction in support of CMC deliverables 
  • Outstanding track record of collaboration, stakeholder relationship management, and influencing key decision makers. 
  • Demonstrated understanding of industry trends, practices, techniques, and standards which impact the business and can translate that knowledge into action plans. 
  • Strong analytical skills and ability to distill key information from various data sources. 
  • Demonstrated technical project management and/or project leadership experience 
  • Proven ability to operate with a high level of ambiguity while making sound and timely decisions based on project priorities and risk assessments. 
  • Demonstrated experience in leading and mentoring talent. 
  • Excellent communication skills – written and verbal. 

Allena Pharmaceuticals is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Director of Process Development

JOB DESCRIPTION:

The Director of Biologics Process Development will be responsible for providing CMC oversight and technical management for process development activities, which includes oversight of upstream and downstream process development conducted at CROs/CDMOs, process optimization using DOE, technology transfer, process validation and QbD regulatory filings. The successful candidate will provide technical leadership regarding global regulatory submissions. 

RESPONSIBILITIES: 

  • Apply insightful, scientific expertise to the direction of internal and external upstream and downstream process development activities for the company’s biologics programs.
    • Design, conduct and oversee laboratory experiments to develop, investigate and/or characterize biologics separation and purification process steps 
    • Work closely with external CROs/CDMOs, collaborators, and/or partners to rapidly advance programs to key decision points. 
  • Design, manage, and interpret experiments to define design space for drug substance process. 
  • Develop and direct strategies for implementation of upstream and downstream processes (including regular interactions with CDMOs/CROs), working in close partnership with analytical development and formulation development. 
  • Assemble and maintain Product Development information repository to allow efficient retrieval of development reports, protocols, specifications, and other relevant documentation 
  • Partner with Project Management, Engineering/Manufacturing, Preclinical, Clinical, and Regulatory functions (typically as part of cross-functional project teams) to ensure that 
  • project development timelines are in place and aligned with the project’s overall objectives. 
  • Author and review technical sections for company’s global regulatory submissions (INDs, IMPDs, BLAs, MAAs, Meeting Requests, Briefing Documents, responses to Health Authority questions, etc.) related to assigned programs. Partner with Project Management, CMC Regulatory, and other Regulatory team members to ensure submission timelines are established and met. Collaborate with external experts/consultants to ensure submission content is aligned with current Health Authority requirements/ expectations. 
  • Proactively collaborate with other members and CDMOs and CROs in relation to the technology transfer, process scale-up, design of validation strategies, and providing technical expertise with regards to routine and nonroutine development and cGMP activities (e.g., deviations/investigations, process improvements, change controls, shelf-life extensions, CAPAs, etc.). 
  • Oversee the development and maintenance of the PD budget including acquisition of appropriate laboratory-scale equipment, cost estimates for laboratory work and third-party vended cost. 
  • Develop and/or provide a technical review of development documents (batch records, experimental data, protocols, reports, analytical methods, SOPs, etc). Support the creation, maintenance, improvement, and routine use of Quality Systems. Contribute to the generation and protection of company intellectual property. 

QUALIFICATIONS: 

Education: 

  • Ph.D. (or equivalent) in Biochemistry, Pharmaceutical Sciences, Chemical Engineering or closely related field. 

Experience (e.g. Jobs, supervisory, industry, international, etc.) 

  • 10+ years’ experience in the pharmaceutical or biotech industry with 5+ years demonstrated leadership in the biologics process development. 
  • Experience with global pharmaceutical/biotech development and manufacturing operations for development-stage biologics. 
  • Must have demonstrated leadership experience in managing diverse project activities with contract CDMO facilities at different global locations, demonstrated scientific knowledge and abilities relevant to biologics development and manufacturing, as well as in-depth knowledge of all stages of the drug development process. 
  • Knowledge of cGMP regulations required. 

Specialized knowledge, Licenses, etc.: 

  • Very strong technical knowledge of pharmaceutical development and manufacturing of biologics, including upstream/downstream process development, preformulation/formulation development and analytical development. Experience with process scale-up and technology transfer, cGMPs, ICH guidelines, as well as the CMC content of global regulatory submissions. 
  • Background in process development and scale up. Personal experience with mammalian process development, tech transfer and scale-up and validation. 

Other skills/attributes: 

  • Demonstrated alignment with company values and culture 
  • Strong tolerance for change and uncertainty as projects evolve 
  • Excellent interpersonal skills in internal and external (i.e. CDMO/CRO management) interactions 
  • Excellent communication skills both written and oral 
  • Excellent time management skills 

Allena Pharmaceuticals is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Clinical Project Manager/Senior Clinical Project Manager

POSITION SUMMARY: 

The CPM/Sr. CPM will play a key role within Clinical Operations in leading clinical study(ies) within timelines and budget scope, and with quality standards. The CPM/Sr.CPM will work closely with cross-functional colleagues and must thrive in a highly entrepreneurial biotech environment. 

RESPONSIBILITIES: 

  • Provide operational management of one or more assigned clinical projects with focus on clinical quality in accordance with FDA, EMEA, GCP, and ICH guidelines and the clinical protocol. 
  • Drive progress and operational excellence for clinical trials from planning to close-out, with focus on adherence to intended timelines and achievement of study deliverables. 
  • Guide vendor selection and management. 
  • Lead site identification and initiation, and patient recruitment strategies. 
  • Lead site training efforts; Plan and present at investigator meetings and vendor meetings. 
  • Manages vendor relationship and performance, including CROs and other vendors. Develop good working relationships with study site staff as required. Contribute to data reviews and CSR. 
  • Manage development of the study related documents, including clinical protocol, informed consent forms, study plans and other study specific clinical documents. 
  • Lead development of eCRF and specifications with data vendor. 
  • Lead cross functional study teams. Lead internal communication of project status. 
  • Track and report on progress of study metrics. 
  • Facilitate the development and implementation of remedial activities. 
  • Support the continued development of departmental practices and Standard Operating Procedures. 
  • Manage invoice review and support the accrual process. 

REQUIREMENTS: 

  • A BS/MS or higher in biological sciences or related field. 
  • Minimum of 5 years of directly related experience is desired. Proven experience in the oversight of the operational aspects of all stages of clinical studies. 
  • Progressive experience in management and conduct of clinical trials (e.g., ICH and regulatory requirements, drug development process, clinical trial material considerations, budgeting and forecasting, trial operational considerations, and clinical compliance). Expertise in monitoring operational functions and working knowledge of data management and cleaning. 
  • Late phase clinical trials and global experience preferred. 
  • Strong organizational/project management/interpersonal skills. 
  • Excellent written, oral/presentation and computer skills. 
  • Ability to travel up to 20 % of the time, as needed. 

Allena Pharmaceuticals, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Process Engineer, Drug Product

POSITION SUMMARY: 

Process engineer will lead global drug product supply chain & manufacturing operations in cooperation with contract manufacturing organizations (CMO) with emphasis on spray drying and drug product manufacturing operations. This position supports the mid and late-stage development and manufacturing of the company’s lead biopharmaceutical product. 

KEY RESPONSIBILITIES: 

  • Represent the company and/or lead process engineering projects in drug product development, scale-up and manufacturing; 
  • Work with the formulation development team to identify, review, and assess product formulations that could improve product quality, reduce cost, improve efficiency, or gain/protect intellectual property; 
  • Design and conduct testing independently or working with CMOs to evaluate process KPPs and CPPs, processing equipment cleaning and sanitization, cost reduction initiatives, or manufacturing capacity strategies; 
  • Represent the company or lead the efforts to validate granulation, blending and encapsulation processes; 
  • Drive the technical and/or logistical support to facilitate the development, scale-up and launch of the company’s lead product; 
  • Provide effective communication through verbal and written reports, timely updates, and knowledge sharing. 

QUALIFICATIONS REQUIRED: 

  • BS in Chemical Engineering with a minimum of 5 years of development and/or manufacturing engineering experience. A technical background in a combination of dry granulation, blending, capsule production and packaging is strongly desired. 
  • Background or experience in physical chemistry/material science and pharmaceutical manufacturing is a plus 
  • Experience in encapsulation, granulation, particle coating, material/physicochemical characterization, colloidal particle interactions, application of physical chemistry and numerical methods to process design, statistical experimental design and data analysis are highly desired and are key aspects of this position. 
  • Adaptable to work on a variety of projects from engineering design to product research and development to manufacturing. 
  • Strong interpersonal skills and ability to work on cross-functional teams and external vendors. 
  • Ability to travel up to 25% as needed. 
  • Preferred computer skills include MS Office applications, process modeling/simulation programs. 

Allena Pharmaceuticals is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

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