Impress employers and recruiters.
Choose from hundreds of resume examples.
Impress employers and recruiters.
Choose from hundreds of resume examples.
Tailor your resume to this Senior Manager, Process Development and Manufacturing role.
Rezi rewrites your resume against Assembly Biosciences, Inc.'s job description. Free.
Tailor your resume to this Senior Manager, Process Development and Manufacturing role.
Rezi rewrites your resume against Assembly Biosciences, Inc.'s job description. Free.
Don't guess if your resume is good enough.
See how it scores against the Senior Manager, Process Development and Manufacturing posting at Assembly Biosciences, Inc. — free, in seconds.
Don't guess if your resume is good enough.
See how it scores against the Senior Manager, Process Development and Manufacturing posting at Assembly Biosciences, Inc. — free, in seconds.
About the Role
The Senior Manager of Process Development and Manufacturing will support process chemistry activities for small molecule compounds, focusing on drug substance manufacturing routes, process scale-up, technology transfers, and CMO coordination.
Responsibilities
- Support drug substance development and manufacturing activities at CMOs to ensure timely delivery of drug substance meeting quality standards.
- Collaborate with CMOs to design, develop, and implement robust chemical synthesis processes for starting materials, intermediates, and APIs.
- Support technical transfer of starting material, intermediates, and API processes between sites.
- Contribute to phase-appropriate synthetic route design and control strategy implementation for starting materials, intermediates, and APIs across early- and late-stage programs.
- Collaborate cross-functionally to ensure seamless transitions between drug substance and drug product programs and CMOs.
- Provide technical support in ensuring that CMO manufacturing facilities are compliant with cGMPs.
- Provide technical review and approval of batch records, deviations, investigations, and technical reports.
- Design and execute experiments for process robustness, optimization, scale-up, transfer, and validation.
- Review and summarize process development results and analytical data from CROs/CMOs.
- Support authoring and reviewing drug substance sections in regulatory submissions, including technical justifications for regulatory questions.
- Function as a highly effective communicator, discussion leader, and team player in a dynamic team culture.
Requirements
- Ph.D. with 3+ years, MS with 6+ years, or BS with 8+ years of small molecule drug substance development experience in the pharmaceutical or biotech industry.
- Strong technical skills and hands-on experience in process chemistry, including in-depth knowledge of drug substance manufacturing equipment.
- Knowledge of global pharmaceutical regulatory requirements (e.g., cGMP, ICH, USP).
- Experience working with CROs/CMOs for drug substance development, manufacturing, and testing.
- Effective communicator with strong interpersonal, collaboration, and time-management skills.
- Self-motivated and adaptable in a fast-paced environment, able to manage multiple projects and shifting priorities.
Location
- South San Francisco, CA
Work Type
- Hybrid
- Regular
- Full-time
- Exempt
Experience Level
- Senior Manager
Education Level
- Ph.D.
- MS
- BS
Salary/Compensations
- $199,400 - $203,700 annualized
About the Company
- Assembly Bio (NASDAQ: ASMB) is an ambitious biopharmaceutical company with cutting-edge therapeutic candidates capable of improving the lives of millions living with devastating viral and liver diseases.
- We have multiple ongoing clinical programs focused on the development of novel treatments for herpesviruses, hepatitis delta virus (HDV), cholestatic liver diseases and hepatitis B virus (HBV).
- Our research organization is dedicated to the discovery of new therapies to change the treatment paradigm for individuals living with serious viral and liver diseases.
- We pride ourselves on creating a culture and work environment that is scientifically driven, ambitious, and collaborative.
- We encourage diversity of thought that leads to great innovation and are looking to add great people to our dynamic team who are driven to transform the lives of patients.
- We set our sights high—and pursue our goals with determination.
- Our unique organization stands ready to welcome talented, motivated individuals, who share our ambitions.
Equal Opportunity
- As an equal opportunity employer, we are committed to diversity and inclusion and will not tolerate discrimination and harassment of any kind.
- All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate.