Original listing text, shown exactly as published by the company.
Key Responsibilities
- Develop and deliver phase-appropriate product understanding and control strategies using QbD framework and risk assessment
- Support manufacture of clinical and commercial GMP DS throughout product lifecycle, including tech transfer, campaign analysis, and diagnostics
- Author and review technical reports, master and executed batch records, working across internal team and with CDMO partners
- Work closely with CDMO partners, providing technical oversight (including onsite Person in Plant support when required), and taking the lead in supporting investigations and resolving deviations
- Analyze process and manufacturing data to understand and optimize process performance
- Develop process characterization and PPQ strategies and documentation
- Support regulatory activities including submissions and site inspections from preparation through execution
- Liaise with DP, device development, and clinical supply chain as needed to ensure seamless end to end product delivery and robustness
- Develop and maintain cost of good models that describe process and enable sensitivity analyses for process improvements
- Collaborate closely with colleagues to ensure a seamless, highly integrated TechOps team
- Author and review internal procedures, reports, and presentations, as needed
Ideal Candidate
- PhD in relevant discipline (e.g., biology, chemistry, biochemistry, bio/chemical engineering, or relevant field) or commensurate years of education and experience
- 7+ years of biologics development and manufacturing experience
- Experience with late phase development and commercialization of monoclonal antibodies within relevant process areas (upstream cell culture, downstream processing, solution prep, cleaning, automation, data systems, etc.)
- Experience with tech transfer to CDMOs and supporting DS campaigns through scale up and validation/PPQ, including person in plant and pre-approval inspection support
- Experience with process and economic modeling of DS manufacturing processes
- Demonstrated aptitude in collaborating with cross-functional partners, including clinical development/operations, analytical development, QA, RA, and supply chain
- Excellent communication skills with an ability to present to a variety of stakeholders and tailor message accordingly
- Demonstrated growth mindset, willing to learn from others, and dedication to promoting a psychologically safe environment
- Ability to multi-task and keep pace with a fast-moving organization
- Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
- Availability to participate in calls across multiple international time zones
- Position requires up to 25% travel including mandatory in-person attendance at All Hands meetings typically held twice per year, additional travel may be required to attend visits to vendors, CDMOs, etc. domestic and international travel is required
The anticipated salary range for candidates for this role will be $175,000-$195,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.
