Akston invents, develops, and manufactures breakthrough protein therapeutics for Companion Animal Health. We leverage our novel Ambifect™ Fc-fusion platform to develop and manufacture new classes of therapeutics. Additionally, Akston serves as a Contract Development and Manufacturing Organization (CDMO) for other Animal Health companies through production and manufacturing facilities dedicated to Animal Health. Our manufacturing facilities, along with our research and process development laboratories, are located in Beverly, Massachusetts.
Position Summary
The Downstream Process Development group at Akston encompasses lab-scale development, pilot-scale operations, and at-scale Manufacturing Science and Technology (MSAT) support. This position is primarily responsible for advancement of Akston's therapeutic pipeline through the development of robust, cost-effective, and scalable processes for new and existing products through all drug development stages. The individual will be involved in hands-on non-GMP lab work as well as providing GMP operational support. Cross-functional collaboration with all other groups in the company, including R&D, Pharmacology, Upstream Process Development, Manufacturing, QA, and QC, is an essential part of this role.
Primary Duties
Process Development:
Act as the subject matter expert (SME) for various mAb and Fc-fusion protein purification technologies and practices, including but not limited to chromatography, column packing, tangential flow filtration (TFF), and viral filtration
Design small-scale process optimization experiments using Design of Experiment (DoE) and Quality by Design (QbD) principles, with a focus on impurity clearance and characterization of Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs)
Perform lab-scale experiments as needed and generate non-GMP drug substance/product to support in-vivo and clinical trial material supply requirements
Analyze analytical assay results, including ELISA, HPLC, CE-SDS, cIEF, peptide mapping, glycan mapping, spectrophotometry, and endotoxin content
Lead project planning and guide CMC strategies for long-term program success
Participate in cross-functional teams to evaluate technical risk and impact of decisions across CMC
Facilitate management of key external vendors, CDMOs, and CTOs
Train, mentor, and coordinate activities of junior staff members
Author technical reports and assist in the preparation of regulatory documents
Manufacturing Support:
Assist with Downstream GMP manufacturing operations to purify up to 1000L bioreactor harvests
Author SOPs, batch records, protocols, change controls, CAPAs, risk assessments, impact assessments, and other GMP Quality documents
Provide technical support for process incident resolution, including deviation and investigation support
Lead technology transfer of new processes to ensure smooth transition from process development to GMP manufacturing
Prospectively project manufacturing material usage, equipment needs, and scheduling to ensure the timelines are met
Support equipment procurement, installation, qualification (IQ/OQ/PQ), validation, and preventative maintenance activities
Drive continuous improvement through the adoption of innovative solutions to enhance efficiency, data analytics, and operational performance
Other Responsibilities & Skills
Demonstrate solid understanding and use of engineering principles and practices to solve a range of complex problems in creative and practical ways
Exercise independent judgment and decision making with minimal supervision and direction, while multitasking between multiple projects to meet challenging deadlines
Exhibit strong verbal and written communication skills, attention to detail, and time management skills
Stay up to date with state-of-the-art purification technologies and actively seek opportunities for continuous improvement
Limited travel may be required (~5%)
Ability to lift up to 25 lbs.
Qualifications
Bachelor's degree in engineering, chemistry, biology, biomedicine, pharmacy, or other related pharmaceutical science and 8+ years of work experience
Master's degree in engineering, chemistry, biology, biomedicine, pharmacy, or other related pharmaceutical science and 6+ years of work experience
Ph.D. in engineering, chemistry, biology, biomedicine, pharmacy, or other related pharmaceutical science and 3 - 5 years of work experience
Experience
The successful candidate shall demonstrate:
Substantial experience in R&D/PD laboratory and GMP manufacturing environments
Experience in team leadership, project management, root cause analysis principles, and process improvement principles such as LEAN or Six Sigma/DMAIC
Proficiency with Microsoft Word, Excel, and PowerPoint
Familiarity with analytical and statistical processing software, such as JMP
Experience with process validation is preferred
Compensation
Title and pay commensurate with skills and experience, eligibility for company benefit plans.
Other
This is an on-site, non-remote position. Must live within commuting distance of Beverly, MA.
Contact
Candidates should send CV and cover letter to careers@akstonbio.com