Associate Director, Analytical Development
Olema Oncology, Boston, MA, United States
Associate Director, Analytical Development
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>>>Associate Director, Analytical Development
As the Associate Director of Analytical Development reporting to the Senior Director of Analytical Chemistry you will be responsible for driving progress of both early and late-stage molecules by delivering phase‑appropriate analytical methods, validation and tech transfers. You will partner with cross‑functionally supporting process development, formulations, CMC, and quality activities. In addition, you will bring demonstrated team‑playing and collaboration skills and experience operating effectively in a fast‑paced, growth‑stage biotech environment.
This role can be based out of our San Francisco, CA or Boston, MA office and will
require 10‑15% travel .
Your work will primarily encompass:
Supporting analytical method development, qualification, and validation for starting materials, in‑process control, process intermediates, drug substances and drug products
Conducting analytical technical review of method validation/qualification protocols, data and reports generated at CDMOs for drug substances and drug products
Reviewing and approving analytical reports or certificates of analyses from CDMOs for batch release and stability testing of drug substances and drug products
Working on stability programs, monitoring/trending stability data and establishing retest periods or shelf lives for drug substances or drug products
Providing technical input and resolving analytical and quality control issues, deviations, OOS and OOT investigations
Supporting regulatory filings (IND, IMPD, NDA, MAA) submissions as needed
Representing analytical Chemistry at internal and external scientific team meetings as needed
Staying 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
MS or PhD in Chemistry or equivalent scientific discipline
Expertise in analytical development and quality control for both drug substances (emphasis) and drug product
Knowledge of cGMP, ICH, and FDA regulations/guidance
Experience
Minimum of 7+ years of relevant industry experience in small molecule drug substance and drug product analytical development and quality control, including late‑stage clinical development and preparation for product registration
Experience working in an environment that strives to ensure internal technical expertise in‑house while driving CDMO capabilities to meet milestones for multiple projects
Experience in partnering with cross‑functional teams providing analytical development leadership across programs and projects
Effective written, oral communication and interpersonal skills
Attributes
Analytical thinking with problem‑solving skills and the ability to adapt to changing priorities and deadlines
Self‑motivated and enthusiastic; fast learner who can identify the core project challenges and expeditiously change course as required in a fast‑paced organization
Teamwork and collaboration; balances team and individual responsibilities; gives and welcomes feedback; puts success of team above own interests; supports everyone's efforts to succeed; shares expertise with others
Aspires to the highest of scientific and ethical standards
Keen to improve processes and overcome inefficiencies
The base pay range for this position is expected to be
$190,000-$205,000
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.
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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>>>Associate Director, Analytical Development
As the Associate Director of Analytical Development reporting to the Senior Director of Analytical Chemistry you will be responsible for driving progress of both early and late-stage molecules by delivering phase‑appropriate analytical methods, validation and tech transfers. You will partner with cross‑functionally supporting process development, formulations, CMC, and quality activities. In addition, you will bring demonstrated team‑playing and collaboration skills and experience operating effectively in a fast‑paced, growth‑stage biotech environment.
This role can be based out of our San Francisco, CA or Boston, MA office and will
require 10‑15% travel .
Your work will primarily encompass:
Supporting analytical method development, qualification, and validation for starting materials, in‑process control, process intermediates, drug substances and drug products
Conducting analytical technical review of method validation/qualification protocols, data and reports generated at CDMOs for drug substances and drug products
Reviewing and approving analytical reports or certificates of analyses from CDMOs for batch release and stability testing of drug substances and drug products
Working on stability programs, monitoring/trending stability data and establishing retest periods or shelf lives for drug substances or drug products
Providing technical input and resolving analytical and quality control issues, deviations, OOS and OOT investigations
Supporting regulatory filings (IND, IMPD, NDA, MAA) submissions as needed
Representing analytical Chemistry at internal and external scientific team meetings as needed
Staying 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
MS or PhD in Chemistry or equivalent scientific discipline
Expertise in analytical development and quality control for both drug substances (emphasis) and drug product
Knowledge of cGMP, ICH, and FDA regulations/guidance
Experience
Minimum of 7+ years of relevant industry experience in small molecule drug substance and drug product analytical development and quality control, including late‑stage clinical development and preparation for product registration
Experience working in an environment that strives to ensure internal technical expertise in‑house while driving CDMO capabilities to meet milestones for multiple projects
Experience in partnering with cross‑functional teams providing analytical development leadership across programs and projects
Effective written, oral communication and interpersonal skills
Attributes
Analytical thinking with problem‑solving skills and the ability to adapt to changing priorities and deadlines
Self‑motivated and enthusiastic; fast learner who can identify the core project challenges and expeditiously change course as required in a fast‑paced organization
Teamwork and collaboration; balances team and individual responsibilities; gives and welcomes feedback; puts success of team above own interests; supports everyone's efforts to succeed; shares expertise with others
Aspires to the highest of scientific and ethical standards
Keen to improve processes and overcome inefficiencies
The base pay range for this position is expected to be
$190,000-$205,000
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.
#J-18808-Ljbffr