Director Analytical Development, CMC

Location
San Francisco, California
Posted
May 20, 2022
Ref
4464700004
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time

Olema Oncology (NASDAQ: OLMA) is a biopharmaceutical company developing innovative targeted therapies for women’s cancers.  Our lead program, OP-1250, a potential best-in-class complete estrogen receptor antagonist (CERAN), is in development to treat estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Olema recently initiated a Phase 1/2 dose-escalation and expansion clinical trial of OP-1250. We are supported in our mission by experienced and accomplished scientists and board members, leading healthcare investors, and some of the most innovative pharma companies. For more information about the company please visit www.olema.com

The Role:

We are seeking an experienced, driven colleague to lead our analytical development and quality control effort. This role will report into the Vice-President, CMC and will be responsible for driving progress of both early- and late-stage molecules by delivering phase-appropriate analytical methods and validation.

This is a fantastic opportunity for a hands-on Director, Analytical Development to join a company with an industry leading Board of Directors and Management team. This CMC leader will roll up their sleeves to help build an innovative women’s oncology company with significant potential to transform breast cancer treatments. 

This position is available in either our San Francisco or Boston office.

What You Will Do:
  • Defining and implementing science-driven, phase-appropriate analytical development and validation strategies and business processes related to all aspects of the Olema portfolio
  • Leading both internal and external teams in analytical method development, qualification, and validation for starting materials, in-process control, process intermediates, drug substances and drug products
  • Authoring appropriate CMC sections to support regulatory filings (IND, IMPD, NDA, MAA) submissions
  • Providing technical input and resolving analytical and quality control issues, deviations, OOS and OOT investigations
  • Representing analytical and quality control at internal and external scientific team meetings
  • Staying current with state-of-the art approaches and applicable global regulations and industry standards

What You Will Bring:

  • MS or PhD in Chemistry or equivalent scientific discipline
  • 10+ years of relevant industry experience and exposure to small molecule drug substance analytical development, including late-stage clinical development and preparation for product registration
  • Minimum 5 years direct leadership experience
  • Expertise in analytical development and quality control for both drug substance and drug product
  • Knowledge of cGMP, ICH, and FDA regulations/guidance
  • Experience authoring and reviewing documents in support of CMC development activities and regulatory submissions (IND/IMPD, information requests, amendments, briefing books, NDA/MAA, etc.)
  • Experience working in an environment that strives to ensure internal technical expertise in-house while driving CDMO capabilities to meet milestones for multiple projects

Personal Characteristics:

Given the “small biotech” nature of the Company, cultural fit of the successful candidate is an important criterion for their success at Olema. Desired characteristics include 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.

Specific personal characteristics include:
  • Excellent verbal and written communication and skills coupled with the ability to advocate for a position and engage in vigorous debate to reach the best decision
  • Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadline
  • A commitment to excellence
  • 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
  • A demonstrated ability to make decisions on incomplete information and in areas where a high degree of professional judgment is required
  • Be a “difference maker” in terms of one’s professionalism and contributions
  • Have impeccable professional ethics, integrity and judgment
  • Be collegial, hard-working, confident, a self-starter and have a passion for results
Additional Information:   We require all employees to be fully vaccinated against COVID-19, subject to approved medical or religious exemptions or disability accommodations.   We 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 provide equal opportunity to all employees and applicants for employment.    Olema offers competitive compensation and benefits. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with a platform to develop their long-term careers.   Please note: Olema does not accept agency resumes and we are not responsible for any fees related to unsolicited resumes. Thank you.