Senior Process Development Engineer
Biospace has been engaged by our client who sells uniquely positioned and harder-to-manufacture generics that bring value to customers and patients. They spend every minute of every day figuring out how to bring historically complex prescription medications to market. Their products are generics of value to the market, not high-volume, mass-produced products.
The Senior Process Development Engineer is a manager-level position that requires a strong understanding and practice of product development, processing and pharmaceutical manufacturing technology of sterile and oral solid dose products. This position will require extensive collaboration with 3rd party developers and manufacturers in late-stage sterile product development including process development, scale up and technology transfer. The successful applicant will possess the following attributes: integrity, self-directed, innovative, highly motivated to succeed, results oriented, a high level of ownership, sense of urgency and accountability.
RESPONSIBILITIES for the Senior Product Development Scientist:
- Develops robust processes for sterile and OSD products.
- Process improvements and cost reduction initiatives to existing marketed products/processes.
- Actively involved in project management and product development strategies. Handle all technical aspects of development projects.
- Proactively ensures GxP compliance.
- Ensure the manufacturability of ANDAs as they advance through the development process; lead technology transfer team, product validation efforts, new product launches and support of the commercialization process.
- Write and/or review protocols, final development reports, batch records, standard operating procedures, and other technical reports to support product development activities and regulatory filings.
- Author and/or review appropriate CMC sections of ANDA submissions.
- Lead the development/optimization of scale-up efforts in the manufacture of drug products.
- Lead project teams; interact with peers including supply chain, QA/RA, R&D project management, and third-party manufacturers to advance projects in a timely and cost-effective way while maintaining quality.
- Successfully develop and execute technology transfer protocols and the transfer of drug product manufacturing processes into a cGMP drug product manufacturing facility.
- Provide technical expertise to CMOs for manufacturing processes.
- Interacts closely with the contract manufacturer to achieve specified objectives. Uses metrics to measure and track CMO performance. Responsible for resolving issues with CDMOs and suppliers.
- Assesses manufacturing requirements and capabilities prior to the transfer of new processes to the manufacturing site; prepares process transfer documentation and leads technology transfer team.
- Travel up to 20% domestic and international.
REQUIREMENTS for the Senior Product Development Scientist:
- Must have a Bachelor's Degree in Pharmaceutical Science or related science with minimum of 5 years of relevant sterile product development experience. Master’s degree preferred.
- Experience with troubleshooting of sterile products in a production environment.
- Experience in process development, process optimization and scale-up of parenteral dosage forms.
- Knowledge in pharmaceutical product development, CMC regulatory requirements, project management; and capability to collaborate closely with colleagues.
- Knowledge of practices and equipment in a GMP manufacturing environment, including closed-systems, single-use/disposable technology, and sterile/aseptic processing.
- Application of advanced automation and statistical data analysis in development, including design of experiments.
- Experience working in a GMP regulated environment. Knowledge of cGMP and an understanding of the concepts of GLP, GCP and FDA guidelines.
- Experienced in aseptic/sterile processing.
- Ability to work with minimal technical supervision and perform operational tasks independently.
- Strong technical and problem solving skills
- Strong verbal and written communication skills and interpersonal skills.
- Highly motivated and driven to acquire new skills.