Olema Oncology
Associate Director, CMC Drug Substance Development and Manufacturing
Olema Oncology, Boston, Massachusetts, us, 02298
Associate Director, CMC Drug Substance Development and Manufacturing
Olema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our pipeline also includes OP-3136, a potent, selective oral inhibitor of the KAT6 pathway. At Olema, we are building a focused team committed to our mission with intention and clarity. For more information, visit us at www.olema.com.
About the Role
Associate Director, CMC Drug Substance Development and Manufacturing, reporting to the Senior Director of CMC Drug Substance. You will support drug substance process development and cGMP manufacturing activities at external CDMOs.
We are looking for an experienced process chemist with a track record of successful oversight of manufacturing small molecule drug substances under cGMP.
In addition to supporting process development activities and managing manufacturing campaigns (including reviews of master and executed batch records), you will contribute to the preparation and review of technical development reports and authoring of the CMC sections of regulatory submissions including INDs, IMPDs, NDAs, etc.
This role is based out of our San Francisco or Boston office and will require up to 10% travel.
Your work will primarily encompass:
Provide technical guidance and lead drug substance process development, manufacturing and CDMO management
Lead technical meetings with CDMOs and provide status updates to internal teams
Represent drug substance function on cross-functional CMC and project teams, providing technical and strategic input
Review manufacturing documentation to enable GMP drug substance production and clinical supply
Collaborate with QA/QC to identify and evaluate deviations, CAPAs and change controls
Collaborate with SMEs in the CMC department on the development and validation of analytical test methods for drug substances at CDMOs
Author and review technical documents, process development reports, and drug substance sections for IND, IMPD and global marketing applications
Stay current with emerging technologies, regulatory trends, and industry best practices in drug substance development
Ideal Candidate Profile
Knowledge and Experience:
M.Sc. or Ph.D. in Organic Chemistry, or related discipline with 8+ years of experience in a CMC development organization
Expertise in small molecule process development and GMP manufacturing, preferably across all phases of development (pre-IND to commercial manufacturing)
Knowledge of GMP for drug substance for clinical studies
Knowledge of global regulatory requirements for manufacture, testing, and control of clinical and commercial drug substance
Demonstrated successful leadership in a pharmaceutical CMC drug substance development role
Experience authoring and reviewing technical documents including development reports, master batch records, analytical testing methods, and specifications
Effective written, oral communication and interpersonal skills
Power-user of Microsoft Office Suite, Chemdraw, SciFinder, etc.
Attributes:
A curiosity-driven, independent work style with a collaborative mindset; strong initiative and cross-functional communication
Highly analytical and detail oriented
Strong data and document organization skills
Self-starter, goal- and data-driven
Ability to multi-task and shift priorities to meet tight deadlines
Aims for the highest scientific and ethical standards
Keen to improve processes and overcome inefficiencies
The base pay range for this position is expected to be $175,000 - $185,000 annually; compensation may vary by location, knowledge, skills, capabilities, and experience. The total compensation package includes equity, bonus, and benefits.
Important Information
We provide equal opportunity to all employees and applicants for employment. Olema is building a culture where the value of difference is celebrated.
We offer a competitive compensation and benefits package and a summary of benefits is available for all applicants.
Fraud Alert: Olema does not conduct interviews via text message and will never request payments or upfront fees. Our official information is available at лема.com and our careers page at olema.com/careers.
#J-18808-Ljbffr
About the Role
Associate Director, CMC Drug Substance Development and Manufacturing, reporting to the Senior Director of CMC Drug Substance. You will support drug substance process development and cGMP manufacturing activities at external CDMOs.
We are looking for an experienced process chemist with a track record of successful oversight of manufacturing small molecule drug substances under cGMP.
In addition to supporting process development activities and managing manufacturing campaigns (including reviews of master and executed batch records), you will contribute to the preparation and review of technical development reports and authoring of the CMC sections of regulatory submissions including INDs, IMPDs, NDAs, etc.
This role is based out of our San Francisco or Boston office and will require up to 10% travel.
Your work will primarily encompass:
Provide technical guidance and lead drug substance process development, manufacturing and CDMO management
Lead technical meetings with CDMOs and provide status updates to internal teams
Represent drug substance function on cross-functional CMC and project teams, providing technical and strategic input
Review manufacturing documentation to enable GMP drug substance production and clinical supply
Collaborate with QA/QC to identify and evaluate deviations, CAPAs and change controls
Collaborate with SMEs in the CMC department on the development and validation of analytical test methods for drug substances at CDMOs
Author and review technical documents, process development reports, and drug substance sections for IND, IMPD and global marketing applications
Stay current with emerging technologies, regulatory trends, and industry best practices in drug substance development
Ideal Candidate Profile
Knowledge and Experience:
M.Sc. or Ph.D. in Organic Chemistry, or related discipline with 8+ years of experience in a CMC development organization
Expertise in small molecule process development and GMP manufacturing, preferably across all phases of development (pre-IND to commercial manufacturing)
Knowledge of GMP for drug substance for clinical studies
Knowledge of global regulatory requirements for manufacture, testing, and control of clinical and commercial drug substance
Demonstrated successful leadership in a pharmaceutical CMC drug substance development role
Experience authoring and reviewing technical documents including development reports, master batch records, analytical testing methods, and specifications
Effective written, oral communication and interpersonal skills
Power-user of Microsoft Office Suite, Chemdraw, SciFinder, etc.
Attributes:
A curiosity-driven, independent work style with a collaborative mindset; strong initiative and cross-functional communication
Highly analytical and detail oriented
Strong data and document organization skills
Self-starter, goal- and data-driven
Ability to multi-task and shift priorities to meet tight deadlines
Aims for the highest scientific and ethical standards
Keen to improve processes and overcome inefficiencies
The base pay range for this position is expected to be $175,000 - $185,000 annually; compensation may vary by location, knowledge, skills, capabilities, and experience. The total compensation package includes equity, bonus, and benefits.
Important Information
We provide equal opportunity to all employees and applicants for employment. Olema is building a culture where the value of difference is celebrated.
We offer a competitive compensation and benefits package and a summary of benefits is available for all applicants.
Fraud Alert: Olema does not conduct interviews via text message and will never request payments or upfront fees. Our official information is available at лема.com and our careers page at olema.com/careers.
#J-18808-Ljbffr