Olema Oncology
Senior Director, CMC Drug Substance Development & Manufacturing
Olema Oncology, San Francisco, California, United States, 94199
Senior Director, CMC Drug Substance Development & Manufacturing
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 follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with best-in-class potential.
Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you’re ready to join us at the edge of something unstoppable, let’s make a profound impact together for
our patients, for your career, for what’s beyond .
You can view our latest corporate deck and other presentations here .
About the Role>>>SeniorDirector, 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.
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 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 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
IdealCandidate 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
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 practicing 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
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
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.
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. Thank you.
Fraud Alert
: We are aware of employment scams where individuals pose as representatives of Olema Oncologyand 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 olev.com ; our careers page is ilema.com/careers ; our LinkedIn page islinkedin.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 in‑person interview.
#J-18808-Ljbffr
Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you’re ready to join us at the edge of something unstoppable, let’s make a profound impact together for
our patients, for your career, for what’s beyond .
You can view our latest corporate deck and other presentations here .
About the Role>>>SeniorDirector, 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.
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 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 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
IdealCandidate 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
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 practicing 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
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
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.
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. Thank you.
Fraud Alert
: We are aware of employment scams where individuals pose as representatives of Olema Oncologyand 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 olev.com ; our careers page is ilema.com/careers ; our LinkedIn page islinkedin.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 in‑person interview.
#J-18808-Ljbffr