Senior Director, Commercial Manufacturing & Operations

Olema Oncology•Boston, MA

1d•Onsite

About The Position

Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Their lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) in development for metastatic breast cancer. Their follow-on product candidate, OP-3136, is a potent KAT6 inhibitor. The company fosters a culture of support, motivation, and challenge, prioritizing people to achieve impactful work. The Senior Director, Commercial Manufacturing & Operations reports to the SVP of CMC & Supply Chain. This role requires an experienced manager with a track record of successful project leadership and oversight of late-stage (registrational, process validation, commercial) manufacturing of small molecule drug substances and drug products. Responsibilities include the execution of technical transfer (including process validation activities), oversight of manufacturing activities, document review, and quality event support for drug substances and drug product. The position is based in Boston, USA, and requires 20% travel.

Requirements

BS/MS/Ph.D. in Chemistry, or related discipline with a minimum of 10+ years of experience, or a business degree with a minimum of 15 years of experience, in a CMC development and manufacturing organization
Sense of urgency, ability to recognize time sensitivity, appetite to lead aggressive activity within the manufacturing function
Flexible and adaptable style, achievement oriented by nature with a willingness and eagerness to take on challenges
Visionary as well as tactile and concrete at an operational level.
Demonstrated successful leadership in a pharmaceutical CMC drug substance and drug product development and manufacturing role
Broad experience working with CDMOs and managing external development and manufacturing partners
Expertise in 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
Thorough understanding of global regulatory requirements for the manufacture, testing, and control of commercial drug substances
Strong communication, negotiation, problem solving and decision-making skills at all levels of the organization, verbally and in writing
Ability to work collaboratively to connect vision, strategy and goals and present plans, justifications and mitigation scenarios to executive management
Effective written, oral communication and interpersonal skills
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.
Highly analytical and detail oriented
Self-Starter
Goal and data driven
Ability to multi-task and shift priorities rapidly to meet tight deadlines
Aspires to the highest scientific and ethical standards
Keen to improve processes and overcome inefficiencies

Responsibilities

Support the US launch of palazestrant in 2027 by creating the commercial supply platform and strategy
Establish an operational commercial mapping of supply and partners (state licenses, 3PL & order-to-cash Services, shipping and import/export logistics, import/export compliance)
Provide technical and functional project leadership on drug substance (DS) and drug product (DP) commercial manufacturing, and CMO management
Develop business processes and systems to support and streamline all DS and DP commercial activities. Work globally to implement processes and systems within Olema’s global CDMO network. Develop metrics and continuous improvement initiatives.
Ensure employees are engaged and tied to the global Olema’s business strategy
Lead or manage 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; ensures timely closure of such investigations
Partner with Commercial, Quality Assurance and CMC Regulatory Affairs SMEs to develop and operate appropriate commercial procedures to ensure the drug substance and drug product meets established quality standards and adheres to established and regulatory agency approved parameters
Work closely with SMEs and CMOs to execute shipment of drug substance batches and drug product lots
Partner with supply chain teams to design DS and DP production schedules while maximizing production and cost efficiencies
Develop, maintain and communicate product manufacturing plans, timelines, milestones and budgets. Integrate and align commercial manufacturing activities with corporate development program objectives. Develop and apply resource and capacity models
Stay current with state-of-the art approaches and applicable global regulations and industry standards