Associate Director, Drug Substance
4 weeks ago
Description
The Associate Director of Drug Substance - EACD will have the primary responsibility to oversight process development and manufacturing activities at external CDMOs to support pre-clinical and clinical programs. The successful candidate needs to demonstrate a proven track record of working in a virtual environment with external CDMOs to manage manufacturing activities of clinical/commercial stage small molecule APIs. Reporting to the Director of EACD, this individual will provide guidance to the external manufacturing partners on raw materials sourcing strategy, document review (batch records, deviation, CAPA, change control etc.), regulatory strategy and most importantly trouble-shooting manufacturing challenges. This role will represent the DS team at the cross-functional meetings and will operate at the interface of other closely related functions (QA, Regulatory, Analytical Science, Drug Product, Supply Chain etc.). Experience in process validation and/or technology transfer and regulatory document preparation (IND/NDA) is highly desirable.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities
The successful candidate will lead the EACD DS development & manufacturing activities through the following areas/interactions:
Responsible for route scouting, process development & optimization, scale-up and manufacturing of drug substance at external CDMOs
Solve technical issues relating to drug substance manufacturing by providing technical expertise & oversight to external CDMOs
Work with quality function to review/manage technical reports and quality documents (such as batch record, change controls, deviations & CAPAs)
Compare and contrast lab and manufacturing process information to provide insights into how efficiencies could be gained, and improvements could be realized
Collaborate with legal and procurement teams to review contract terms and execution of agreements.
Keep up with the latest process chemistry and regulatory literature and guidance.
Maintain and grow a network of CDMOs maintaining geographical diversity
Manage process validation & technology transfer activities (as needed) at external CDMOs
Develop phase-appropriate manufacturing timelines & plans, participate in CDMO technical selections, and manage successful execution of these plans consistent with overall program budget & timelines
Serve as the drug substance technical lead on CMC teams and coordinate activities with regulatory, drug product, analytical and supply chain functions
Identify key knowledge gaps and execute plans to ensure necessary process understanding is gained
Ensure that the manufacturing is compliant with both relevant regulations and regulatory commitments.
Requirements
Master's Degree (e.g. MBA, MSc) or equivalent in chemistry, chemical engineering, or pharmaceutical sciences from an accredited institution, with ten-plus (10+) years of experience; OR
Ph.D. degree from an accredited institution with eight-plus (8+) years of industrial experience in synthetic chemistry or chemical engineering (i.e.: process research, development, manufacturing)
Proven track record of solving manufacturing challenges and continuous process improvements
Understanding and knowledge of cGMP/ICH regulations and ability to apply them to drug substance development and manufacturing
Excellent verbal and written communication skills.
Strong interpersonal communication skills, proven ability to participate and maintain collaborative, effective internal and external relationships.
Experience in drafting CMC sections of regulatory documents (IND/NDA)
Ability to travel to domestic and overseas manufacturing partner sites (approximately 20-30 % of time)
Onsite/Flex*:
This position is site based with flexibility for remote working. Working onsite a minimum of 2-3 days per week is required. Remote working norms will be clarified during the interview process.
Compensation Data
This position offers a base salary typically between $135,000.00 and $232,000.00 USD. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here.
Eligibility Requirements
Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required)
Must be 18 years of age or older
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