Job Description

Senior Director, CMC Drug Substance Development & Manufacturing

Join to apply for the Senior Director, CMC Drug Substance Development & Manufacturing role at Olema Oncology .

Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our followon product candidate, OP-3136, is a potent KAT6 inhibitor with bestinclass potential.

We believe that when we put people first, our work becomes second to none. If youre ready to join us at the edge of something unstoppable, lets make a profound impact together for our patients, for your career, for whats beyond.

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About the Role

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 latestage (registrational, process validation, commercial) manufacturing of smallmolecule drug substances. You will be responsible for the execution of technical transfer, oversight of manufacturing activities, document review, quality event support, and preparation and review of technical development reports and relevant CMC sections of regulatory submissions (INDs, IMPDs, NDAs, etc.).

This role will be based out of either our San Francisco or Boston office and will require 10% travel.

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; ensure 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 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 stateoftheart approaches and applicable global regulations and industry standards

Ideal Candidate Profile

Knowledge and experience:

• 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 smallmolecule 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

Attributes:

• A high level of curiosity, intelligence, ability to work independently, can do attitude, and ability to work crossfunctionally. Strong initiative and followthrough are essential for this job
• Demonstrated ability to collaborate effectively within crossfunctional teams
• Specific personal characteristics include:
  • Highly analytical and detail oriented
  • SelfStarter
  • Goal and data driven
  • Ability to multitask and shift priorities rapidly to meet tight deadlines
  • Aspires to the highest scientific and ethical standards
  • Motivated to improve processes and overcome inefficiencies

Compensation

The base pay range for this position is expected to be $270,000 - $290,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

Equal Opportunity

We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated.

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 longterm careers. A Summary of Benefits is available for all applicants.

Fraud Alert

Please note: Olema doesnt accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.
We are aware of employment scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers. To protect yourself, please note that Olemas official email addresses end in @olema.com. Our official corporate website is olev.com; our careers page is olev.com/careers; our LinkedIn page is linkedin.com/company/olema-oncology. Please visit these links for official information from Olema. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without an inperson interview.

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