Director, Process Chemistry
Chemistry | South San Francisco, CA | Full Time
Director, Process Chemistry
Plexxikon, a member of the Daiichi Sankyo Group, is a leader in the discovery and development of novel, small molecule pharmaceuticals. The company utilizes its proprietary discovery platform to successfully develop a portfolio of competitively differentiated clinical and preclinical stage compounds in a number of therapeutic areas. Plexxikon’s most advanced program, Zelboraf™ (vemurafenib) was the first oral targeted therapy to be approved for the treatment of both metastatic and unresectable melanomas. Plexxikon's demonstrated capability in discovery and early development uniquely positions the company to develop multiple commercial franchises for different therapeutic indications, and to create significant value for Plexxikon, Daiichi Sankyo and patients.
Plexxikon's novel discovery approach, combined with experienced management and scientific teams, a broad network of scientific and clinical experts, and partnerships supporting later stage development, have been key drivers of the company's success since it began operations in 2001. Plexxikon is a small business with approximately 70 employees based in South San Francisco, California.
The Director of Process Chemistry will be a critical member and decision maker reporting to the Sr. Vice President of Research. The scope of the position runs from process design and development through manufacturing and regulatory submission. This is an exceptional opportunity with high visibility to lead a key function in a successful biotech company with 2 marketed drug products.
Responsibilities include, but are not limited to:
- Develops an overall API strategy including timelines, budgets, risk & mitigation plans for all API process development and manufacturing campaigns
- Directs synthetic route scouting and optimization to design phase-appropriate synthetic routes and implement regulatory control strategies for GMP manufacturing
- Reviews, authors, and approves manufacturing process documentation such as process development protocols and reports, batch records, validation protocols and reports, specifications, etc.
- Manages external CRO/CDMO activities to achieve on-time delivery of non-GMP and GMP materials from gram scale to multi-kilogram quantities
- Oversees technical solutions to ensure that API processes are successfully demonstrated and delivered
- Leads selection and sourcing of starting materials for API and the setting of API specifications
- Leads selection of API CDMO manufacturers
- Oversees characterization of physical properties and selection of API form including polymorph and salt screening studies in collaboration with Pharmaceutical team
- Directs the identification, preparation and characterization of impurities and degradation products
- Evaluates and approves external work orders related to API process development and manufacturing
- Authors appropriate CMC sections to support regulatory (IND, IMPD, etc.) submissions
- Partners with various functions in the company (Chemistry, Quality, Regulatory, Pharmaceutics, Clinical Development, Project Management, Business Development, Materials Management) to maximize productivity in all aforementioned responsibilities
- Evaluates and proposes improvements to process chemistry operations at Plexxikon
- Writes experimental protocols, technical, and development reports capturing details of experiments conducted and conclusions drawn
- Writes progress reports and gives presentations at various meetings
- Maintains electronic laboratory notebook for all experimental work performed
- Maintains a command of new scientific literature and regulatory/quality requirements for pharmaceutical products and evaluates implications for company programs
- Other related duties as assigned
- PhD in Chemistry with at least 10 years of industry experience in process chemistry in the biotechnology/pharmaceutical industry
- A high level of expertise in all areas of process chemistry, in depth knowledge of the principles and practices of pharmaceutical science, and mastery of emerging, innovative technologies
- Direct hands-on experience in process chemistry research and development
- At least 3 years experience in a leadership position
- Previous experience managing projects at CROs/CMOs
- Extensive experience with drug development and broad knowledge of regulatory and quality requirements for pharmaceutical products
- Experience with authoring regulatory documents for IND and NDA filings for new chemical entities
- A strong track record of accomplishments in developing and implementing robust and efficient drug substance manufacturing processes
- Experience working in a GMP environment and previous regulatory submissions would be a plus
- Excellent interpersonal, verbal, and written communication skills
- Effective troubleshooting and problem-solving skills
- Comfortable in a fast-paced small company that requires flexibility to adjusting workloads based upon changing priorities and willingness to be a team player in order to accomplish project goals regardless of level or type of work
Plexxikon, an equal opportunity employer, and will be based in SSF as of August 2021. We offer a chance to work with talented people in a collaborative environment and provide top-notch benefits including health insurance, generous time off, annual performance bonuses, long-term incentives and much more.
If you are interested in applying for this opportunity, please submit your resume or CV, cover letter and salary requirements. All submissions will be evaluated, and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year. To learn more about Plexxikon, please visit our website at www.plexxikon.com .
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