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Associate Director, Drug Substance

4 months ago

Ridgefield, United States BI Pharmaceuticals, Inc. Full time

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**:

- 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
- 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**:
**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