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 >>> Senior Director, Commercial Manufacturing & Operations

As the Senior Director, Commercial Manufacturing & Operations reporting to the SVP of CMC and Supply Chain, you will be 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. 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 and drug product.

This role is based out of our Dublin, Ireland office and will require 20% travel.

Your work will primarily encompass:

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
Provide site leadership with awareness of employee needs at all levels of the site, ensuring 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

Ideal Candidate 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:

BS/MS/Ph.D. in Chemistry, or related discipline with a minimum of 10+ years of experience, or a business degree with 15+ years of experience, in a CMC development and manufacturing organization
Minimum of 3 years direct leadership experience
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

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.

Specific personal characteristics include:

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

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Important Information >>>

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 Oncology and 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 olema.com; our careers page is olema.com/careers; our LinkedIn page is linkedin.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.

Senior Director, Commercial Manufacturing & Operations

Job Description