Senior Director, CMC Drug Substance Development & Manufacturing

Olema Oncology • Boston, MA

2d • $270,000 - $290,000

About The Position

Senior Director, CMC Drug Substance Development & Manufacturing Reporting to the SVP of CMC & Supply Chain, the Senior Director of CMC Drug Substance Development & Manufacturing is an experienced process chemist with a proven track record of successful project leadership and oversight of late-stage (registrational, process validation, commercial) manufacturing of small molecule drug substances. You will be responsible for the execution of technical transfer (including process validation activities), oversight of manufacturing activities, document review, quality event support, etc. for drug substances. In addition, you will be responsible for the preparation and review of technical development reports and relevant CMC sections of regulatory submissions including INDs, IMPDs, NDAs, etc. This role will be based out of either our San Francisco or Boston office and will require 10% travel.

Requirements

• Ph.D. in Organic Chemistry, or related discipline with a minimum of 12+ years of experience, or Master with a minimum of 15+ years of experience, in a CMC development organization
• A minimum of 5+ years of direct people management and leadership experience
• Demonstrated successful leadership in a pharmaceutical CMC drug substance development role
• Broad experience working with CDMOs and managing external development and manufacturing partners
• Expertise in small molecule process development and oversight of GMP manufacturing, including tech transfer and process validation
• Understanding of supplier performance management (quality metrics, adherence to supply and quality agreements) and familiarity with commercial supply agreement negotiations
• Experience authoring and reviewing technical documents including, but not limited to, development reports, master batch records, analytical testing methods, and specifications
• Thorough understanding of global regulatory requirements for the manufacture, testing, and control of clinical and commercial drug substances
• Demonstrated success with authoring drug substance sections of INDs, IMPDs, and marketing applications, and practice responding to inquiries from regulatory agency reviews
• Effective written, oral communication and interpersonal skills
• Publications in peer reviewed journals and patent applications record
• A high level of curiosity, intelligence, ability to work independently, “can do” attitude, and ability to work cross-functionally.
• Strong initiative and follow-through are essential for this job
• Demonstrated ability to collaborate effectively within cross-functional teams
• Highly analytical and detail oriented
• Self-Starter
• Goal and data driven
• Ability to multi-task and shift priorities rapidly to meet tight deadlines
• Aspires to the highest scientific and ethical standards
• Motivated to improve processes and overcome inefficiencies

Responsibilities

• Provide technical and functional project leadership on drug substance process development, manufacturing, and CMO management
• Create and disseminate technical transfer information and documentation required for familiarization, transfer, validation and routine manufacturing
• Collaborate with SMEs within the CMC department on the development and validation of analytical test methods for drug substances
• Lead or support documentation review and approval (MBRs, specifications, analytical methods, etc.), change controls and documentation for internal batch disposition
• Oversee investigations related to deviations to assess impact to product and manufacturing process; ensures timely closure of such investigations
• Partner with Quality Assurance and CMC Regulatory Affairs SMEs to develop and operate appropriate CMC procedures to ensure the drug substance meets established quality standards and adheres to established and regulatory agency approved parameters
• Work closely with SMEs to execute shipment of drug substance batches
• Partner with supply chain teams to design API production schedules while maximizing production and cost efficiencies
• Author and review technical documents, process development reports, and drug substance sections for IND, IMPD and global marketing applications
• Stay current with state-of-the art approaches and applicable global regulations and industry standards

Benefits

• We offer a competitive compensation and benefits package
• seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers.
• A Summary of Benefits is available for all applicants.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 101-250 employees