Amunix Operating Inc. is seeking an experienced, hands-on individual to join our expanding team in the role of Associate Director/Director, Purification Process Development. He/She will manage the downstream process development activities and support CMC strategies across the product development cycle, including recovery/purification process development, process scale up, tech transfer and analytical development for a broad portfolio of products. In addition, he/she will ensure that products manufactured to support pre-clinical and clinical studies are in compliance with the requisite regulations and guidelines.
Downstream Process Development:
- Provide strategic direction, tactical oversight and technical expertise to process work aimed at the development of optimized processes that lead to sustained manufacturing consistency, robustness, scalability, increased efficiency and reduced costs.
- Collaborate with Upstream Development and Analytical Development functions to define and execute appropriate process development and testing strategies; plan and oversee additional studies and other activities required to transition products from research into the clinic.
- Oversee development and/or improvement of processes and products to achieve in-house and external partner objectives for bioavailability, product storage, shelf-life, and stability.
- Evaluate program gaps from an in-process tool- and analytical methods development perspective. Define and implement required analytical development work to ensure the success of active product development programs from research through to clinical/commercialization.
- Partner with Analytical Development and Quality functions to oversee the method qualification/methods transfer activities in cooperation with contract manufacturers/ testing labs/partnering entities.
- Support transfer of downstream processes to partnering entities. Foster and maintain strong relationships with contract manufacturers/testing labs/partnering entities for drug substance purification/synthesis, including oversight of technology transfer to/from contract manufacturers/testing labs/partnering entities.
- Collaborate with Analytic Development, contract manufacturers/testing labs/partnering entities to oversee the refinement/tightening of manufacturing process controls and product release specifications in step with production capabilities and the advancement of product development programs from discovery through clinical development and commercialization. Oversee the advancement of related analytical methods/in-process methods that sustain continuous improvement in establishing purity and stability specifications of BDS/API that align with required clinical, regulatory and CMC-specific, quantitative product specifications over time.
- Oversee the planning, internal approvals, and operational management of downstream development team members, in-house production schedules, reflecting material supply needs for research, product development, preclinical and clinical studies.
- Provide required support to the Quality function to establish, implement, maintain, and document appropriate quality standards for development and manufacturing of BDS/API.
- Prepare technical reports to support planned regulatory submissions and future process development work. Review technical documentation, including technology transfer protocols, validation protocols, technical reports, manufacturing and labeling information to ensure conformance with regulations and existing regulatory approvals.
- Support successful preparation of CMC sections of regulatory submissions, as required. Participate in completing CMC responses to regulatory agency questions/correspondence and negotiations with the FDA to resolve CMC related regulatory issues, as required.
Desired Skills & Experience
- M.S. or Ph.D. in Biochemistry, Chemical Engineering or related biochemical sciences with 5-10 years of industry experience. Experience with bacterial fermentation derived products and protein/peptide conjugation chemistry desirable.
- Demonstrated experience and track record of success in a bioprocess development/product development function in a pharmaceutical or biotech company.
- Demonstrated track record of success in developing and improving processes (purification/conjugation synthesis) for production of proteins, peptides and related conjugation chemistry at mid- to large-scale.
- Experience with tech transfer to contract manufacturers/testing labs/partnering entities. Strong organizational and supervisory skills and ability to coordinate/advance multiple project activities at multiple sites/partners.
- Working knowledge and hands-on operating experience with standard downstream process development centrifuges, separators, homogenizers, chromatography and MF/UF skids.
- Experience with analytical methods such as SDS-PAGE, ELISA, HPLC, MS, LC-MS, CE.
- Working knowledge of cGMP regulations and ICH and CDER guidelines applicable to the development and production of starting materials, API, and Drug Product.
- Experience preparing successful CMC sections of regulatory submissions (IND’s/NDA’s) and interacting with FDA and foreign regulatory authorities desirable.
- Ability to effectively lead and participate on multi-disciplinary teams.
- Strong interpersonal skills and excellent oral and written communication skills.
- Strong initiative and desire to work in a fast paced, team-oriented dynamic environment.
We are a biopharmaceutical company developing first-in-class products using our novel half-life extension technology.
- Contribute to a company experiencing high growth and undergoing significant expansion
- Work in a highly collaborative and motivated working environment
- Comprehensive benefit package available, including health, dental, vision, short-term and long-term disability
- Compensation will be based on candidate experience
If interested, please contact: firstname.lastname@example.org.