Vice President, Chemistry, Manufacturing and Controls \/ Biologics

Location
San Diego, California, United States
Posted
Jan 29, 2021
Ref
od0odfwy
Hotbed
Biotech Beach
Required Education
Doctorate/PHD/MD
Position Type
Full time
Vice President, Chemistry, Manufacturing and Controls / Biologics


SITUATION OVERVIEW

  • Pre-IPO, clinical stage biotech with lead asset in Ph 1 and potential for first-in-class mechanism
  • First precision medicine approach to GI therapeutics, with platform attracting strong partners
  • Global exclusive license to Cedars-Sinai's GI biobank and bioinformatics platform
  • Fully capitalized with top-tier investor syndicate


Prometheus is a pre-IPO biotechnology company pioneering a precision medicine approach to the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment and diagnosis of inflammatory bowel disease (IBD). The company's precision medicine platform, Prometheus 360, combines proprietary bioinformatics discovery methods with one of the world's largest gastrointestinal bioinformatics databases to identify novel therapeutic targets and develop therapeutic candidates to engage those targets. Prometheus is a spin out of Cedars-Sinai Medical Center and partners with the hospital system for its biospecimens, clinical data, and bioinformatics.

The company is led by an exceptional management team bringing deep experience in GI and autoimmune therapies. CEO Mark McKenna joined in 2019 to refocus the organization around a precision therapeutics strategy after orchestrating a successful turnaround effort at Salix Pharmaceuticals. Mark and the executive team are guided by Prometheus' board of directors, led by Chairman Tachi Yamada, M.D., and a scientific advisory board composed of key opinion leaders in IBD, including Stephan Targan, M.D., William Sandborn, M.D. and Dermot P. McGovern, M.D., Ph.D.

The company recently secured a $130 million Series D financing with a top-tier syndicate and is attracting best-in-class collaboration partners such as Takeda and Dr. Falk. With a lead therapeutic program in Phase 1 studies and a robust emerging pipeline, the company is seeking a best-in-class immunologist to lead all of Prometheus' preclinical development efforts and be accountable for delivering a sustainable pipeline of drug candidates, from target validation through IND submission.

SUMMARY

The successful candidate will be responsible for all CMC activities across Prometheus' portfolio of therapeutic antibodies, including analytical, formulation and process development, as well as all manufacturing and stability campaigns. The Vice President, CMC will be responsible for creating and executing a comprehensive CMC strategy, ensuring both technical success and on-time delivery of results and clinical material.

Outsourced manufacturing:
  • Plans all aspects of manufacturing process development and GMP manufacturing projects, from API to Drug Product, using outside vendors.
  • Provides expertise and is responsible for vendor selection, management of the manufacturing process, regulatory compliance and selection of any equipment and human resources required to complete the process within budgetary constraints.
  • Reviews, benchmarks and recommends vendors for best outcomes with justifiable expenditures.
  • Negotiates contracts with outside vendors (pharmaceutical manufacturers, consultants) on production of active pharmaceutical ingredients and Drug Products for both development and marketed pharmaceutical products/services or research and development for the company. Ensures the contracts are executed as per agreement and to ensure that all required activities are properly performed to support regulatory filings.
  • Develops and implements methods and procedures for monitoring manufacturing projects such as documentation of expenditures and research findings, progress reports and staff conferences to inform management of current status of each project.


Development sciences:
  • Monitor stability trending and oversee formulation development, including high concentration subcutaneous formulations and defines combination product strategy. Implement stage-appropriate analytical method development.


Regulatory fillings:
  • Manages CMC (chemistry, manufacturing and control) aspects of therapeutic projects and prepares relevant sections for regulatory submissions. Works with regulatory affairs department staff to ensure submissions to regulatory authorities are of the highest quality and on schedule.
  • Represents company in CMC meetings with the FDA and other regulatory agencies.
  • Defines registration batches timing and validation strategy based on project timeline. Owns and maintains a long-term plan for late-stage development of all recombinant protein programs.
  • Works with RA/QA to establishes the audit process of vendors to ensure compliance with all regulatory agencies connected with research, development, manufacturing, packaging and distribution of both development and marketed pharmaceutical products for the company.
  • Remains up-to-date with changes in regulatory policies and guidelines, including cGMP.
  • When required, contributes to defining the best clinical formulation strategy for early trial phases by anticipating bridging with a commercial type formulation.


EDUCATION and/or EXPERIENCE

Position generally requires a bachelor's, masters or doctoral degree in a biology, chemistry or biochemistry with a minimum of 15 years related experience or equivalent combination of education and experience. Significant experience working in an FDA regulated pharmaceutical environment bringing monoclonal antibody or recombinant proteins from research through development and into GMP production. Previous experience delivering CMC programs utilizing contract manufacturing organizations required. Project management skills strongly desired. Some experience with small molecule CMC programs desirable but not required.

VALUES IMPORTANT TO US
  • Growth with integrity
  • Collaborate to succeed
  • Embrace clarity
  • Embody ingenuity
  • People first
  • Respect
  • Passion
  • Innovation
  • Engage in teamwork
  • Deliver value and excellence


All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, veteran status or other protected class.