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.

To be considered for one of the positions below, please complete the form below and send us your resume. 

Associate Director/Director, Regulatory Affairs

Description

The AD/Director of RA is responsible for planning and coordinating all aspects of regulatory submissions necessary to support product development, clinical trials and product registration for Allena’s development programs.

Who are we looking for?

  • An innovative person who will partner Allena’s Regulatory Affairs team in the execution of their goals.
  • Ability to work with a small dynamic team

What are we looking for?

  • Ownership:  A partner to jointly own Regulatory focused company’s goals for successful execution 
  • Working together:  A colleague to thrive on collaboration with our teammates
  • Building strong relationships internally and externally to drive results

What are we offering?

  • Strategic role for overall Regulatory development for Allena’s Reloxaliase 
  • Membership within a growing, CARING and collegial organization
  • Exposure to pioneering science of the therapies that utilize the GI tract to degrade metabolites

Responsibilities:

  • Serve as the regulatory lead on multidisciplinary project teams
  • Work with Regulatory management to develop and implement regulatory strategy for assigned projects in all stages of development (pre-IND/pre-CTA through approval and life-cycle management)
  • Author regulatory documents in support of filings including INDs/CTAs, Briefing Materials for Health Authority meetings, Pediatric Plans (US & EU), Expedited Pathway Applications and Marketing Applications
  • Plan, manage and execute regulatory activities, including submission and maintenance of global regulatory filings (FDA, EMA & ROW) to meet strict deadlines
  • Participate as an active team member and provide strategic regulatory advice to project teams as required
  • Work collaboratively on cross-functional teams taking a problem-solving approach identifying regulatory risks with proposals for risk mitigation
  • Work independently with minimal direction and within project teams, committees, etc. to attain group goals
  • Serve as a liaison within internal departments at Allena with CROs and with regulatory program managers at HAs
  • Remain current on Regulatory Intelligence, new guidance documents and competitive information in order to provide fully informed information to teams and development programs
  • Support or lead non-project activities, as needed (i.e. SOP/standards development, organizational initiatives) for regulatory compliance

Education and Experience: 

  • Bachelor's degree with 6 or more years of experience in a Regulatory Affairs role; minimum of 6 years’ experience working in the biotech or pharmaceutical industry
  • RAC certification and/or advanced degree desired 
  • Experience in interfacing with relevant regulatory authorities
  • Experience and knowledge in the preparation of major regulatory submissions e.g., INDs, CTAs, Annual Reports, Safety Reporting, etc.
  • Understanding of regulations and experience in interpretation of guidelines with requisite technical system skills to support global submissions

This Position may require up to 20% travel

Competencies:

Adaptability: Responds resourcefully, flexibly, and positively when faced with new challenges, transitions, and demands. Willingly and effectively deals with the stress and complexities of various situations. Moves forward productively and optimistically under conditions of change and uncertainty.

Collaboration: Embodies and promotes collaboration and works effectively with others across the organization to achieve goals. Demonstrates proficient cross-company communication, cultural sensitivity, and partnership in interactions with others. Involves others in decisions and plans and credits them for their contributions and accomplishments.

Communication: Creates an environment which promotes the free flow of communication and information throughout the organization. Communicates effectively in large and small groups. Openly shares knowledge and expertise. Listens actively and encourages the open expression of ideas and opinions.

Execution: Drives execution of strategic and operating plans while maintaining operational effectiveness. Conveys a strong sense of urgency around continuous improvement, achieving high quality results, and accelerating business performance. Addresses problems directly and drives changes necessary to achieve business objectives.

Relationship Building: Establishes and maintains strong relationships internally and externally. Respects and relates well to management, colleagues, peers, and direct reports. Champions a culture of respect, diversity and inclusion that values and respects individuals. Earns the respect of others through principled leadership, sound business ethics, and authenticity.

Location: Sudbury, MA

When You Join Allena You Will Have:

  • Free parking, Newton location reachable by public transportation (Green Line)
  • Customized and competitive health coverage including medical offered through BCBS (HMO/PPO), dental, and vision
  • Flexible Spending Accounts for medical and dependent care expenses
  • Eligible from the first day for 401K with 100% match of the first 4%
  • Robust package of Allena paid insurance coverage, including life insurance, short-term and long-term disability
  • 15 days of vacation and 5 personal days per year, in addition to 13 company holidays and 2 floating holidays
  • Winter Break: Allena is closed for a Winter Break between Christmas and New Year

TO ALL AGENCIES: Please, no phone calls or emails to any employee of Allena about our openings. All resumes submitted by search firms/employment agencies to any employee at Allena via email, the internet or in any form and/or method will be deemed the sole property of Allena, unless such search firms/employment agencies were engaged by Allena for this position and a valid agreement with Allena is in place. In the event a candidate who was submitted outside of the Allena agency engagement process is hired, no fee or payment of any kind will be paid.

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.

Scientist, Formulation Development

Description

The Scientist, Formulation Development will interface with a diverse team across CMC, pre-clinical, and clinical to facilitate the development of robust, scalable, and reproducible oral enzyme therapeutics.  The individual chosen will have broad experiences in designing, executing, and leading activities with oral solid dosage formulations (immediate- and modified-release tablets and capsules), from benchtop to scaleup.

Who are we looking for?

  • A creative and focused Scientist able to consistently deliver results to drive projects forward
  • A colleague to join our lab as both an individual and team contributor with opportunities to make an impact 
  • A team member with positive energy who is passionate about asking questions and finding answers
  • A professional with experience establishing and maintaining relationships internally and externally 

What are we looking for?

  • A driven professional who knows how to work and contribute to an everchanging fast paced work environment
  • A willingness to learn new things, adapt to new ways, and passionate about finding answers
  • A person who thrives in a small company atmosphere
  • Ability to determine task priority and maintain established deadlines

What are we offering?

  • Membership within a growing, CARING and collegial organization with a commercializing oral enzyme therapeutic focus
  • Opportunity to embrace autonomy, have an influence, and make an impact on a small team
  • Internal and external facing role with the opportunity to gain knowledge and career development
  • Exposure to pioneering and growth within the PD and CMC teams

Responsibilities:

  • Collaborate with cross functional team members (pre-clinical, Analytical Development, QC, clinical groups, etc.) to define formulation requirements and limitations for early and late-stage assets.
  • Independently and/or in collaboration with Contract Development Manufacturing Organizations (CDMOs) develop phase appropriate oral solid dosage formulations for immediate or modified release.
  • Executes well-designed experiments to define quantitative and qualitative formulation composition.
  • Conduct design of experiments (DoE) studies to identify and investigates key and critical quality attributes to confirm formulation robustness as per ICH Q8.
  • Design and carry out experiments in support of formulation development using traditional solid-state and solution state analytical techniques, including but not limited to UV-Spectroscopy, Dissolution, HPLC analysis, particle size and flow measurements. 
  • Evaluate data, interpret results, formulate relevant and scientifically based conclusions, and write and present technical reports.

Education and Experience: 

  • A PhD or MS in Pharmaceutical Sciences or related discipline with relevant experience in formulation of oral solid dosage forms.  
  • Hands-on experience with typical tablet and capsule manufacturing processes:  blending, wet and dry granulation, compression, in-process controls, and film coating. 
  • Knowledgeable of immediate- and modified-release oral solid dosage forms. 
  • Experience with solid-state properties of excipients and formulations.
  • Knowledge of analytical methods and instrumentation used for the characterization of solution. 
  • Familiar with design of experiments (DoE) and statistical tools to assess formulation robustness.
  • Experienced with form selection/characterization, pre-formulation, and formulation development of scalable oral solid dosage forms.
  • Experience authoring and reviewing development reports. 
  • Ability to succeed both independently and within a cross-functional team.
  • Excellent written and verbal communication skills and ability to influence across multiple functions.
  • Experience working with proteins and spray drying is a plus

This Position may require up to <10% travel

Competencies:

Adaptability: Responds resourcefully, flexibly, and positively when faced with new challenges, transitions, and demands. Willingly and effectively deals with the stress and complexities of various situations. Moves forward productively and optimistically under conditions of change and uncertainty.

Collaboration: Embodies and promotes collaboration and works effectively with others across the organization to achieve goals. Demonstrates proficient cross-company communication, cultural sensitivity, and partnership in interactions with others. Involves others in decisions and plans and credits them for their contributions and accomplishments.

Communication: Creates an environment which promotes the free flow of communication and information throughout the organization. Communicates effectively in large and small groups. Openly shares knowledge and expertise. Listens actively and encourages the open expression of ideas and opinions.

Execution: Drives execution of strategic and operating plans while maintaining operational effectiveness. Conveys a strong sense of urgency around continuous improvement, achieving high quality results, and accelerating business performance. Addresses problems directly and drives changes necessary to achieve business objectives.

Relationship Building: Establishes and maintains strong relationships internally and externally. Respects and relates well to management, colleagues, peers, and direct reports. Champions a culture of respect, diversity and inclusion that values and respects individuals. Earns the respect of others through principled leadership, sound business ethics, and authenticity.

Location: Sudbury, MA

When You Join Allena You Will Have:

  • Free parking, Newton location reachable by public transportation (Green Line)
  • Customized and competitive health coverage including medical offered through BCBS (HMO/PPO), dental, and vision
  • Flexible Spending Accounts for medical and dependent care expenses
  • Eligible from the first day for 401K with 100% match of the first 4%
  • Robust package of Allena paid insurance coverage, including life insurance, short-term and long-term disability
  • 15 days of vacation and 5 personal days per year, in addition to 13 company holidays and 2 floating holidays
  • Winter Break: Allena is closed for a Winter Break between Christmas and New Year

TO ALL AGENCIES: Please, no phone calls or emails to any employee of Allena about our openings. All resumes submitted by search firms/employment agencies to any employee at Allena via email, the internet or in any form and/or method will be deemed the sole property of Allena, unless such search firms/employment agencies were engaged by Allena for this position and a valid agreement with Allena is in place. In the event a candidate who was submitted outside of the Allena agency engagement process is hired, no fee or payment of any kind will be paid.

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 Director/Director, IT

Description

The Associate Director/Director, IT will lead our information technology function. Reporting to the COO/Finance, this individual, as the first internal leader of the company's information and technology operations, will collaborate closely with colleagues, senior management and other stakeholders to assess user needs and build a strategy and systems to improve business processes, drive security and help deliver the company’s overall strategic growth objectives.  The successful candidate will work cross-functionally to find, implement, and continuously improve practical and scalable technology solutions.

Who are we looking for?

  • A strategic IT professional able to drive projects forward and consistently deliver results 
  • A team leader with positive energy who is passionate about asking questions and finding answers.
  • A driven professional who knows how to work and contribute to an everchanging fast paced work environment and will thrive in a small company atmosphere.
  • A self-starter professional with experience establishing and maintaining relationships internally and externally. 

What are we looking for?

  • A willingness to learn new things, adapt to new ways, and passionate about finding answers.
  • Ability to determine task priority and maintain established deadlines.

What are we offering?

  • Membership within a growing, CARING and collegial late-stage clinical organization with an oral enzyme therapeutic focus.
  • Opportunity to embrace autonomy, have an influence, and make an impact on a small, but growing team.
  • Internal and external facing role with the opportunity to gain knowledge and career development.

Responsibilities:

  • Responsible for establishing the vision, overall IT strategy of Allena in support of R&D and general business operations. 
  • Responsible for day-to-day operations of network, data management, security, enterprise architecture (including R&D systems) and telecommunications (including phone and video conferencing).
  • Design and implement all technology initiatives for the organization.
  • Strategically oversee, integrate, and manage vendor as part of our outsourced IT model.  Proactively manage and partner with the vendor to implement cost efficient improvements.
  • Oversee and implement all IT policies, procedures and plans for security, data, computers, and infrastructure based on industry-standard best practices. 
  • Establish controls and ensure compliance (including SOX compliance) with all industry best practices and relevant regulatory requirements. 
  • Provide direction and support to protect the security (cyber security) and integrity of and increase the value of all information used by the company. 
  • Engage and partner with senior leaders and teams process owners to leverage emerging technologies to address strategic enterprise goals and functional challenges.
  • Ensure deployment of IT systems for new hires and new programs.
  • Identify problematic areas and contribute to strategic solutions.
  • Ensure employee productivity and positive user experience by partnering with key stakeholders and delivering best in class service management.
  • Ensure the growth of the overall IT organization is structured and aligned to help drive the desired scalable growth.

Education and Experience: 

  • 7+ years of relevant experience, BS or MS with a focus in Information Technology.
  • 5+ years of experience in a Biotech/Pharmaceutical company.
  • Experience managing SOX compliant cloud-based technology environments and systems.
  • Stakeholder-focused individual with experience scaling up an IT team in a fast-paced growing business environment.
  • A collaborative management style and a strong customer service orientation.
  • Excellent knowledge of technical management, information analysis and of computer hardware/software systems
  • Hands-on experience with computer networks, network administration and network installation
  • Ability to work collaboratively with end-users to resolve problems and issues is a must.
  • Experience with the following would be a plus: Office 365, Active Directory, Azure, SharePoint, etc.
  • Conference room infrastructure
  • Anti-virus/EDR
  • Preferred experience in a regulated, public, pharmaceutical environment

Competencies:

Adaptability: Responds resourcefully, flexibly, and positively when faced with new challenges, transitions, and demands. Willingly and effectively deals with the stress and complexities of various situations. Moves forward productively and optimistically under conditions of change and uncertainty.

Collaboration: Embodies and promotes collaboration and works effectively with others across the organization to achieve goals. Demonstrates proficient cross-company communication, cultural sensitivity, and partnership in interactions with others. Involves others in decisions and plans and credits them for their contributions and accomplishments.

Communication: Creates an environment which promotes the free flow of communication and information throughout the organization. Communicates effectively in large and small groups. Openly shares knowledge and expertise. Listens actively and encourages the open expression of ideas and opinions.

Execution: Drives execution of strategic and operating plans while maintaining operational effectiveness. Conveys a strong sense of urgency around continuous improvement, achieving high quality results, and accelerating business performance. Addresses problems directly and drives changes necessary to achieve business objectives.

Relationship Building: Establishes and maintains strong relationships internally and externally. Respects and relates well to management, colleagues, peers, and direct reports. Champions a culture of respect, diversity and inclusion that values and respects individuals. Earns the respect of others through principled leadership, sound business ethics, and authenticity.

Location: Newton, MA & Sudbury, MA

When You Join Allena You Will Have:

  • Free parking, Newton location reachable by public transportation (Green Line)
  • Customized and competitive health coverage including medical offered through BCBS (HMO/PPO), dental, and vision
  • Flexible Spending Accounts for medical and dependent care expenses
  • Eligible from the first day for 401K with 100% match of the first 4%
  • Robust package of Allena paid insurance coverage, including life insurance, short-term and long-term disability
  • 15 days of vacation and 5 personal days per year, in addition to 13 company holidays and 2 floating holidays
  • Winter Break: Allena is closed for a Winter Break between Christmas and New Year

TO ALL AGENCIES: Please, no phone calls or emails to any employee of Allena about our openings. All resumes submitted by search firms/employment agencies to any employee at Allena via email, the internet or in any form and/or method will be deemed the sole property of Allena, unless such search firms/employment agencies were engaged by Allena for this position and a valid agreement with Allena is in place. In the event a candidate who was submitted outside of the Allena agency engagement process is hired, no fee or payment of any kind will be paid.

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.

Manager, External Manufacturing

Description

The Manager, External Manufacturing will interface with a diverse team across CMC, Clinical Operations, and Quality, to enable proactive forecasting of development and clinical trial needs to drive external technical transfer and production activities at all phases.  The individual chosen will be responsible for generating, maintaining, and executing end-to-end manufacturing plans for early stage and late-stage programs and will manage day-to-day production activities; inclusive of providing on-site plant support, when feasible.   

Who are we looking for?

  • A creative, focused, and dedicated External Manufacturing professional able to consistently deliver results to drive projects forward
  • A colleague to join our team as both an individual and team contributor with opportunities to make an impact 
  • A team member with positive energy who is passionate about asking questions and finding answers
  • A professional with experience establishing and maintaining relationships internally and externally 

What are we looking for?

  • A results driven professional who knows how to work and contribute to an everchanging fast pace working environment
  • A willingness to learn new things, adapt to new ways, and go with the flow
  • A person who thrives in a small company atmosphere working towards commercialization
  • A strategic mindset with the ability to determine task priority and maintain established deadlines

What are we offering?

  • Membership within a growing, CARING and collegial organization 
  • Exposure to pioneering science of the therapies that utilize the GI tract to degrade metabolites
  • Opportunity to support Clinical and Non-Clinical projects and initiatives
  • Opportunities for mentoring and career development 

Responsibilities:

  • Collaborate with and manage external vendors, such as Contract Research Organizations (CROs), Contract Development Manufacturing Organizations (CDMOs), and Contract Manufacturing Organizations (CMOs) throughout product development life cycle for oral solid dosage forms. 
  • Ensure appropriate technical, scale-up and production strategies and timelines are in place to meet development, clinical supply and registration needs in collaboration with cross functional partners (Analytical, QA, QC, etc.)
  • Draft and review protocols, manufacturing batch records and related documentation and author technical reports.
  • Provide onsite support for manufacturing activities at CMOs or CDMOs, as needed.
  • Responsible for CDMO operations in scale up and manufacture for spray drying in addition to development projects for new activities.
  • Experience with a spray dryer and spray drying
  • Coordinate and manage transportation and logistics for overseas and domestic shipments.

Education and Experience: 

  • Degree in Manufacturing or Life Sciences, BS/5+ or MS/5+ years of relevant industry experience.
  • Experience in drug product manufacturing operations of oral solid dosage and technical support.
  • Strong understanding of cGMP/GCP processes and experience with international labeling, shipping, and import/export of clinical supplies. 
  • Experience with technical project management, technology transfer and vendor management. 
  • Excellent written and verbal communication skills and ability to influence across multiple functions.
  • Ability to succeed both independently and within a cross-functional team.
  • Strong organizational and problem-solving skills.

This Position may require up to 20% travel

Competencies:

Adaptability: Responds resourcefully, flexibly, and positively when faced with new challenges, transitions, and demands. Willingly and effectively deals with the stress and complexities of various situations. Moves forward productively and optimistically under conditions of change and uncertainty.

Collaboration: Embodies and promotes collaboration and works effectively with others across the organization to achieve goals. Demonstrates proficient cross-company communication, cultural sensitivity, and partnership in interactions with others. Involves others in decisions and plans and credits them for their contributions and accomplishments.

Communication: Creates an environment which promotes the free flow of communication and information throughout the organization. Communicates effectively in large and small groups. Openly shares knowledge and expertise. Listens actively and encourages the open expression of ideas and opinions.

Execution: Drives execution of strategic and operating plans while maintaining operational effectiveness. Conveys a strong sense of urgency around continuous improvement, achieving high quality results, and accelerating business performance. Addresses problems directly and drives changes necessary to achieve business objectives.

Relationship Building: Establishes and maintains strong relationships internally and externally. Respects and relates well to management, colleagues, peers, and direct reports. Champions a culture of respect, diversity and inclusion that values and respects individuals. Earns the respect of others through principled leadership, sound business ethics, and authenticity.

Location: Sudbury, MA

When You Join Allena You Will Have:

  • Free parking, Newton location reachable by public transportation (Green Line)
  • Customized and competitive health coverage including medical offered through BCBS (HMO/PPO), dental, and vision
  • Flexible Spending Accounts for medical and dependent care expenses
  • Eligible from the first day for 401K with 100% match of the first 4%
  • Robust package of Allena paid insurance coverage, including life insurance, short-term and long-term disability
  • 15 days of vacation and 5 personal days per year, in addition to 13 company holidays and 2 floating holidays
  • Winter Break: Allena is closed for a Winter Break between Christmas and New Year

TO ALL AGENCIES: Please, no phone calls or emails to any employee of Allena about our openings. All resumes submitted by search firms/employment agencies to any employee at Allena via email, the internet or in any form and/or method will be deemed the sole property of Allena, unless such search firms/employment agencies were engaged by Allena for this position and a valid agreement with Allena is in place. In the event a candidate who was submitted outside of the Allena agency engagement process is hired, no fee or payment of any kind will be paid.

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.

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