Director, Process Development & Manufacturing
Location: South San Francisco, California, United States
The Director of Process Development and Manufacturing will develop robust synthetic processes and deliver non-GMP & GMP drug substance on multi-kilogram scale in a safe and efficient manner. This individual will be responsible for implementing strategies to progress compounds from preclinical development through commercialization with specific focus on delivering drug substance to support clinical and commercial needs for all of Assembly’s small molecule API assets.
Key responsibilities include:
- Lead a team of scientist(s) to conduct route optimization to deliver non-GMP & GMP material on multi-kilogram scale.
- Serve as point of contact to work with CMOs to manage process development and manufacturing of intermediates and API.
- Responsible for phase appropriate synthetic route design and implementation of control strategies for regulatory starting materials, intermediates and APIs.
- Applies working knowledge of synthetic organic chemistry to optimize or develop new manufacturing routes for small molecule API manufacturing processes.
- Demonstrates leadership by implementing a lifecycle approach to API manufacturing that includes taking responsibility for inventories, schedules, batch strategies, documentation, on site supervision (when appropriate), CMO interactions, and logistics.
- Lead fate and purge studies and genotoxic impurity evaluation.
- Work cross-functionally to communicate process chemistry timelines and objectives. Lead and/or participate in relevant CMC meetings.
- Author and review the relevant CMC sections for all regulatory filings.
- Work with quality assurance to manage the release of GMP drug substance and resolve technical issues or deviations.
- Review and approve master batch records, validation protocols/reports and specifications required for drug substance manufacturing.
- Work with medicinal chemistry to ensure rapid transition of compounds into clinic by optimization of the synthetic route and final form evaluation.
- Anticipates and communicates issues to manager, project teams, and senior management (as appropriate) in a timely manner.
- Plans activities and prepares RFPs, tech transfer packages, and any other required documentation to initiate strategic partnerships and contribute to Assembly’s long-term supplier network strategy.
- Identify procedural and systemic gaps internally and with external partners to implement improvements, SOPs, and best practices.
Not sure if you are qualified for this position? We know that skills and experience can show up in different ways and we welcome resumes from a broad range of applicants. You are encouraged to apply even if you do not meet each of the listed preferred qualifications.
- Typical experience for a Director usually includes a PhD with about 10 years of small molecule development. Non-PhD candidates with additional years of experience are encouraged to apply.
- Demonstrated leadership and interpersonal skills that have enabled you to successfully hire, develop, and retain employees. This includes aligning employees around a common vision and goals, and utilizing complementary strengths and experience to create high-performing teams
- A collaborative and flexible leadership style that allows you to adapt to the nuances of managing a diverse team and the on-going training, coaching, and performance management that results in increased engagement and retention.
- Knowledge of current Good Manufacturing Practices (cGMP).
- Ability to manage multiple projects and quickly adapt to changing program needs.
- Experience within SharePoint, VEEVA, MS Teams, SmartSheet or other collaborative information sharing systems is a plus.
- Should be self-motivated, think independently, and possess the flexibility to undertake assignments which might be outside his/her area of expertise.
- Excellent oral and written communication skills.
- Good attention to detail and time management skills.
- Recognizes the importance of integrity, a strong work ethic, information sharing, and productive communication within a highly dynamic and fast paced working environment.
- Previous people management skills preferred
As a condition of employment, you will be required to show proof that you are fully vaccinated by your first day of employment. You are considered fully vaccinated two weeks after your second dose in a 2-dose series, (Pfizer or Moderna vaccines), or two weeks after a single-dose vaccine, (Johnson & Johnson’s/Janssen vaccine). If you are unable to be vaccinated for a medical or disability-related reason, or a deeply held religious belief, Human Resources will discuss potential exemptions and accommodations with you.
About Assembly Bio
Assembly Bio is a clinical-stage biotechnology company committed to bringing finite and curative therapies to the 270 million people living with hepatitis B virus (HBV) worldwide. A pioneer in the development of a new class of potent, oral core inhibitor drug candidates, Assembly Bio’s approach aims to break the complex viral replication cycle of HBV to free patients from a lifetime of therapy. Assembly Bio’s strategy includes a leading portfolio of more potent, next-generation core inhibitors, proof-of-concept combination studies for HBV cure and research programs focused on the discovery of additional novel antiviral mechanisms for HBV, and other viral diseases. For more information, visit assemblybio.com.
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.
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.
Information for Recruitment Agencies
Assembly Bio does not accept from recruiters/agencies any unsolicited resumes, or any candidate information including blinded resumes and will not be responsible for any fees related to resumes or candidate information that is unsolicited. Please do not contact hiring managers or Assembly Bio employees directly with any information related to a resume or a candidate. We handle all recruiting through our internal Human Resources team, and we will reach out to you directly should we wish to engage in a search. Your willingness to comply with this will significantly impact any decision we may make about doing business with you.
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