The Senior Manager of Formulation and Drug Product Development (CMC) will be responsible for providing scientific, technical, and operational oversight for drug development and formulations development from lead optimization through commercialization. This position includes, but is not limited to, leading pre-formulation, formulations development, Drug Product (DP) configuration development, interface with CROs, CDMOs, GMP contract manufacturing organizations (CMOs), oversight of DP manufacturing, preparation and authoring of CMC sections for regulatory filing. The candidate should have strong technical, communication and interpersonal skills, and work across diverse, cross-functional teams.
- Lead and oversee scientific, strategic, planning and execution of biologics formulation development, drug product development and validation including process selection and scale-up, packaging and labeling development, technology transfer, and drug product characterization.
- Play a supporting role in the selection of Drug Product CMOs. Manage contract development and manufacturing organizations, and appropriate consultants to deliver on technical objectives.
- Build and execute drug product development plans for clinical supplies through commercialization.
- Leverage strong analytical capabilities in physicochemical and biophysical methods to interpret data and design studies.
- Participate in drug product regulatory strategy development, author and review regulatory filings, participate in meetings with global regulatory agencies.
- Provide person-in-plant (PIP) support for critical manufacturing operations.
- Responsible for the management and approval of cGMP-compliant documentation (master batch records, SOPs, etc.), as well as the post-manufacturing review and close-out of executed batch records
- Manage deviation/OOS investigations, determine root cause, assess product impact, and implement appropriate CAPAs.
- Author and/or review appropriate CMC sections of regulatory filings. Apply advanced technical writing skills to produce reports and documents; writes independently and evaluates the writing of others.
- Work cross functionally, leading or participating in matrix teams and integrating development with drug substance process development, commercial, preclinical, clinical, regulatory, supply chain and quality.
- Formulate and recommend operational/ technical standard and practice documents for supporting continuous process improvements and product life-cycle management.
- Develop and manage budgets.
- Other duties as may be assigned.
- PhD with 6 years relevant experience within pharmaceutical drug development or equivalent.
- Established experience working with contract development and manufacturing organizations in a leadership role.
- Extensive experience in biologics formulation development within the biotechnology or pharmaceutical industry.
- Strong knowledge of protein and peptide formulations, stability assessment, and characterization technique.
- Demonstrated ability to lead technical drug product development projects including technology transfers to CMOs and working in matrix environments.
- Strong understanding of CMC technical, regulatory, and commercial driver aspects of late-stage biopharmaceutical development developed through direct experience working on Ph3 programs through commercial launch.
- Experience with pre-filled syringes, auto injectors and device development a significant plus
- Experience with analytical methods used to support biologics drug product development, characterization and stability testing including statistical design of experience (DoE) and Quality by Design (QbD) is preferred.
- Excellent problem-solving skills, with the ability to analyze complex data and make informed decisions.
- Strong understanding of regulatory requirements and experience in contributing to regulatory filings.
- Excellent written and verbal communication skills, with the ability to effectively collaborate and influence with cross-functional teams.
- Solid organizational and time management skills
- Project management skills and computer proficiency (JMP, MS Project, Excel, Word, Power Point)
- Ability and willingness to travel 10% of the time (internationally and domestically)
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus in order to read.
The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job, typically in an open office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate.
May be required to travel by plane or car.
This position requires working with biological and/or chemical hazards.
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
$128k-$165k, 15% bonus, 10% 401k,Stock options/RSU