Associate Director, Process Chemistry

BioSpace; United States; In loco; USD 120.000 - 160.000; Tempo pieno

Descrizione del lavoro

A bio-pharmaceutical company is seeking an Associate Director, Process Chemistry to manage drug substance manufacturing and process development. The ideal candidate will oversee novel synthetic route inventions, manage CDMO relationships, and possess a PhD in chemistry with at least 8 years of experience. This role allows remote work with occasional travel. The company values diversity and invites candidates from all backgrounds.

Competenze

• 8+ years of industry experience if holding a PhD; 12+ years if holding an MS or BS.
• Strong understanding of synthetic organic chemistry and process chemistry.
• Experience managing CDMOs and regulatory submissions.

Mansioni

• Oversee all aspects of drug substance manufacturing process development.
• Invent synthetic routes and develop robust manufacturing processes.
• Author regulatory filings and respond to questions from agencies.

Conoscenze

Organic chemistry

Technical writing

Project management

Problem-solving

Regulatory understanding

Formazione

PhD in chemistry or related sciences

MS or BS degree in chemistry or related sciences

Descrizione del lavoro

Position Summary

Associate Director, Process Chemistry will be responsible for overseeing all aspects of Immuneering’s small molecule drug substance manufacturing process development program, from candidate nomination through the clinical development stage of the product lifecycle. This position requires experience in inventing novel, robust, efficient and scalable synthetic routes that comply with all relevant regulatory requirements, and implementing them at scale for early to late-stage development. This position also requires a thorough understanding of the principles of quality by design (QbD), and extensive experience in scientific technical writing for drug development and regulatory submissions. Prior experience managing small molecule drug substance process development and manufacture at CROs and CDMOs is also critical for this position. The successful candidate will be a highly motivated, proactive team player with a strong background in organic chemistry and a proven track record of accomplishments. This position will report to the Head of CMC. This position can be remote based in the US but the hired individual must be available to travel to Immuneering work locations for company meetings and other work partner sites as needed (up to approximately 20%).

Job Functions and Responsibilities

• Invent synthetic routes and develop safe, robust, and cost-effective manufacturing processes
• Direct drug substance manufacturing process development, technology transfer and manufacturing campaigns at external CDMOs, including development, review and approval of process development protocols, master batch records and manufacturing campaign reports
• Review and approve executed batch records, and provide technical review and approval for quality investigations and batch disposition records
• Assist in establishing critical quality attributes and critical process parameters for drug substances in development
• Ensure optimal process performance through process understanding, modeling and characterization, and process performance review
• Contribute to the expansion of Immuneering’s intellectual property portfolio for drug substances
• Author or revise development reports and risk assessments
• Author assigned CMC sections to support regulatory filings (such as IND, IMPD, NDA, MAA) and respond to questions from regulatory agencies
• Serve as drug substance SME for cross-functional project teams
• Collaborate within CMC and across the wider development team to deliver quality drug substance for clinical trials within required timelines
• Serve as a technical expert and keep current in the field of organic and process chemistry
• Possess a deep understanding of global regulatory requirements and emerging trends
• 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
• Evaluate, negotiate/establish contracts and manage relationships with CROs/CDMOs for drug substance process development and manufacture
• Work in compliance with cGMP, safety and regulatory requirements

Required Education, Skills and Qualifications

• PhD in chemistry, chemical engineering or related sciences with 8+ years of industry experience; or MS or BS degree in chemistry, chemical engineering or related sciences with 12+ years of industry experience
• A foundational understanding of organic chemistry, solid form sciences, and process chemistry
• Strong understanding of synthetic organic chemistry reactions, techniques and processes
• Experience in small molecule drug substance process development, technology transfer and manufacture
• Application of QbD principles to the drug development process
• Experience managing CDMOs for research, development and manufacturing campaigns
• Solid understanding of relevant FDA, EU, and ICH regulatory guidelines as applicable to drug substance manufacturing, and current standards of practice in the industry
• Demonstrated ability to apply regulatory guidance to formulate practical solutions and development strategies
• A critical and strategic thinker with exceptional decision making skills and the ability to work independently in a fast-paced, high‑pressure setting
• Excellent technical writing skills; experience with authoring regulatory submissions and responding to regulatory questions
• Values‑based leadership and commitment to integrity and ethics in pharmaceutical product development and manufacture

Preferred

• Experience in IND/IMPD and NDA/MAA submissions is highly preferred
• Experience with drug substance process validation is highly preferred
• Experience in developing patent applications
• Experience in managing quality investigations
• Experience with modern analytical techniques and process analytical technologies (PAT)
• Experience with modeling and simulation tools, and predictive analytics
• Project management skills including the ability to manage project resource requirements (material, manpower, time, etc.), and ability to elevate relevant issues to project lead and line‑management
• Self‑motivated, detail‑oriented, with a continuous quality improvement mindset, high personal integrity, and excellent time management and organizational skills
• Excellent communication, problem‑solving skills; thrives in a cross‑functional team environment

Additional Information

• Travel: 10 to 20%
• Location: Remote

Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission.