Olema Oncology
Senior Director, CMC Drug Substance Development & Manufacturing
Olema Oncology, San Francisco, California, United States, 94199
Senior Director, CMC Drug Substance Development & Manufacturing
Join to apply for the Senior Director, CMC Drug Substance Development & Manufacturing role at Olema Oncology.
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 execution of technical transfer—including process validation activities—oversight of manufacturing activities, document review, quality event support, and more. Additionally, you will prepare and review technical development reports and relevant CMC sections of regulatory submissions including INDs, IMPDs, NDAs.
This role is based out of either our San Francisco or Boston office and requires 10% travel.
Your work will primarily encompass:
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 on 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 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.
Ideal Candidate Profile A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.
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.
Minimum 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 development reports, master batch records, analytical testing methods, and specifications.
Thorough understanding of global regulatory requirements for manufacturing, 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 cross‑functionally. Strong initiative and follow‑through are essential for this job.
Demonstrated ability to collaborate effectively within cross‑functional teams.
Specific personal characteristics include:
Highly analytical and detail oriented.
Self‑starter.
Goal and data driven.
Ability to multi‑task and shift priorities rapidly to meet tight deadlines.
Aspiring to the highest scientific and ethical standards.
Motivated to improve processes and overcome inefficiencies.
The base pay range for this position is expected to be
$270,000 - $290,000
annually. Total compensation also includes equity, bonus, and benefits.
Important Information 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 long‑term careers. A Summary of Benefits is available for all applicants.
Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes.
Fraud Alert: 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 Olema’s official email addresses end in @olema.com. Our official corporate website is olem.com, and our careers page is olem.com/careers. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message or 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 in‑person interview.
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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 execution of technical transfer—including process validation activities—oversight of manufacturing activities, document review, quality event support, and more. Additionally, you will prepare and review technical development reports and relevant CMC sections of regulatory submissions including INDs, IMPDs, NDAs.
This role is based out of either our San Francisco or Boston office and requires 10% travel.
Your work will primarily encompass:
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 on 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 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.
Ideal Candidate Profile A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.
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.
Minimum 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 development reports, master batch records, analytical testing methods, and specifications.
Thorough understanding of global regulatory requirements for manufacturing, 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 cross‑functionally. Strong initiative and follow‑through are essential for this job.
Demonstrated ability to collaborate effectively within cross‑functional teams.
Specific personal characteristics include:
Highly analytical and detail oriented.
Self‑starter.
Goal and data driven.
Ability to multi‑task and shift priorities rapidly to meet tight deadlines.
Aspiring to the highest scientific and ethical standards.
Motivated to improve processes and overcome inefficiencies.
The base pay range for this position is expected to be
$270,000 - $290,000
annually. Total compensation also includes equity, bonus, and benefits.
Important Information 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 long‑term careers. A Summary of Benefits is available for all applicants.
Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes.
Fraud Alert: 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 Olema’s official email addresses end in @olema.com. Our official corporate website is olem.com, and our careers page is olem.com/careers. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message or 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 in‑person interview.
#J-18808-Ljbffr