Scientist, Analytical Development
Allena Pharmaceuticals, Inc. is a late-stage clinical biopharmaceutical company dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders. Allena’s lead product candidate, reloxaliase, is a first-in-class, oral enzyme therapeutic for the treatment of hyperoxaluria, a metabolic disorder characterized by markedly elevated urinary oxalate levels and commonly associated with kidney stones, chronic kidney disease and other serious kidney disorders. Its second product candidate, ALLN-346, is also a first-in-class, oral enzyme for the treatment of hyperuricemia and gout in the setting of advanced chronic kidney disease.
The company’s proprietary technological approach enables the design, formulation and delivery of non-absorbed and stable enzymes orally and in sufficient doses for activity in the GI tract. This approach results in enzyme therapies that utilize the GI tract to degrade metabolites, such as oxalate and urate, reducing plasma and urine levels, and in turn reducing their disease burden on the kidney over time. Led by a proven management team with deep expertise in protein therapeutic design and development, Allena is committed to bringing breakthrough new treatments to patients with unmet medical needs. Allena is based in Newton, MA, with an office and laboratory in Sudbury, MA.
Scientist, Analytical Development
The Analytical Development QC Scientist will be responsible for directing and performing bioanalytical assays to support method qualification and pre-validation related workflows. Successful candidates should have strong laboratory experience in a regulated environment, experience working with proteins and large molecules, and well-developed report writing skills.
Who are we looking for?
- Energetic individual who will work with the Analytical Development and Quality Control teams to lead method qualification activities
- A proven performer who can inject creative problem solving and direct method simplification
- Experience working in or with a regulated laboratory is required
What are we looking for?
- A creative and focused analytical scientist, able to creatively address novel problems
- An accomplished individual with a track record of successful method qualification and requisite documentation
- One who is comfortable in a fast-paced environment where priorities can change quickly
- A colleague to join our lab as both an individual and team contributor
- A team member with positive energy who is passionate about asking questions and finding answers.
What are we offering?
- An opportunity to grow with the Analytical Development department and within CMC
- An opportunity to interface with QC and across external GMP laboratories within Allena CMO/CTL network
- Exposure to pioneering science of therapies that utilize the GI tract to degrade metabolites
- Design, perform and record analyses for method qualification and supporting qualified and validated methods.
- Review data and reports as
- Develop and review laboratory procedures in collaboration with QC personnel.
- Provide training and participate in method troubleshooting efforts for validated methods at external labs
- Provide data summaries, presentations, and detailed
- Lead method qualification
- Coordinate research stability studies in conjunction with stability management program
- Participate in cross-functional meetings to support internal and external partners
- Be accountable for ensuring proactive execution of work
- Assist in maintaining a clean, safe
- Maintenance of laboratory notebook and records in accordance with laboratory requirements, including timely recording and
Education and Experience:
- Education in Analytical Chemistry, Biochemistry, Molecular Biology or related field and industry experience
- PhD (1-3 years).
- Intellectual curiosity and creativity.
- Ability to function in a small company, collaborative atmosphere and dynamic work environment.
- Knowledge of basic statistics (SD, RSD, etc.).
- Hands on experience performing several of the following techniques: Bioassays, ELISA, HPLC, SDS-PAGE, capillary electrophoresis, immunoblots, dynamic light scattering, powder flow evaluation and spray drying.
- Demonstrated oral and written communication
- Willingness to collaborate with QC department to develop protocols and procedures
- Willingness to travel to external labs for analytical support as required
- Commitment to teamwork and continuous improvement.
- Ability to focus attention to details and ensure high quality
- Competence to work safely and encourage safe Can function in a chemical laboratory environment; should have no known sensitivities to chemicals present in the laboratory and no health conditions that preclude working in a chemical laboratory environment.
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.
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 14 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 résumés submitted by search firms/employment agencies to any employee at Allena via email, the internet, or in any other 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.