Tech Transfer Project Lead

2 weeks ago

San Francisco, United States Softworld Inc Full time

Job Title: Tech Transfer Project Lead

Location: San Francisco CA 94107 Remote

Job Description:

The Tech Transfer Project Lead, Drug Substance Development and Manufacturing will oversee key scientific, regulatory, and business functions pertaining to process chemistry for the organization.
Responsibilities include oversight of late development/launch preparation activities including (but not limited to): the development of chemical processes for active pharmaceutical ingredients (APIs) and regulatory starting materials (RSMs), process scale-up, technology transfer, and validation of chemical processes.
Effective management of CROs and CMOs will be a key strategy and activity required to accomplish the functions mentioned.
The position will also contribute to overall strategy and authoring of Module 3 drug substance sections of regulatory submissions by provision of required scientific data and document review.

Responsibilities:

Proven leadership experience in managing drug substance development teams at various experience levels internally (direct report mgmt.) and externally (CRO/CMO mgmt.)
Manage multiple CMOs/CROs to deliver final bulk active drug substance (incl. intermediates) of sufficient quality and quantity to meet corporate and regulatory requirements.
Create and disseminate technical transfer information and documents required by CROs/CMOs to develop and scale up chemical processes and develop analytical methods.
Establish and maintain business relationships with CROs and CMOs appropriate for performing process development requirements.
Compose key terms for/review/execute contracts with, and manage the activities of, CROs/CMOs required to deliver process development tasks on time and within established budgets.
Maintain in-depth knowledge of chemical steps, manufacturing processes, and quality controls.
Ensure that CRO/CMO activities and other process development activities address drug substance needs for pharmaceutical formulation development, toxicology testing, clinical trials, and commercial launch.
Ensure that all chemical processes are developed to deliver on company targets of cost, quality, safety, environmental, and operability needs.
Maintain a working knowledge of manufacturers and suppliers of chemical raw materials, reagents, and intermediates capable of addressing the process requirements of the company in a timely and economical manner.
Identify and lead key process problem resolution activities and process improvement initiatives.
Lead scale-up, process development, process engineering, and finalization (validation) of process for commercial-scale manufacturing.
Extract scientific data and provide appropriate document review to support regulatory filings and commercialization in a timely manner.
Create a culture of continuous improvement and high-performance teamwork.
Continually seek and implement process development best practice methodologies.
Work closely with QA function to develop and operate to appropriate CMC procedures, and to ensure the product meets established quality standards.
Support authorship, review, and response to queries on all Module 3 drug substance development sections of CTD. Expected to contribute to the overall regulatory strategy for the encaleret program (responsible for DS and consulted for DP strategy)
Preference will be given to candidates with prior NDA/MAA authoring experience. Prior NCE filing experience a plus.

Education, experience & skills requirements:


Minimum of Ph.D. (ideally chemistry, chemical engineering) with 7+ years relevant experience, or BS/MS with 10+ years relevant experience
Demonstrated experience in managing API chemical development, process validation, and manufacturing in support of NDA marketing applications and commercial production.
Demonstrated track record of delivering drug substance candidate(s) into chemical manufacturing and commercialization.
Demonstrated chemistry development at an industrial scale.
Significant project leadership experience
Strong aptitude and demonstrated experience in synthetic organic chemistry.
Working knowledge of modern analytical separation techniques pertaining to the separation/purification of organic compounds
Working knowledge of analytical methods development and validation
Familiarity with FDA and ICH guidelines for INDs/NDAs/MAAs and cGMPs
This position will also require a thorough understanding of cGMP, quality, and regulatory requirements, including the preparation and writing of key sections of regulatory documents (such as NDAs, MAAs, and INDs)
Experience in managing CMOs, scientific collaborations, and contracted R&D
Ability to effectively interface with and/or manage highly skilled internal staff.
Training and education in organic synthesis
Working knowledge of process economics
Ability to work independently as well as in a team; ability to build good work relationships.
Strong attention to detail and time management skills
Excellent oral and written communication skills

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