Team Photograph: Photograph for Director, Biologics Drug Product Development

Across the healthcare continuum, there is a shared common concern regarding rising drug spend and drug pricing. EQRx’s innovative business model addresses the profound need for a more collaborative approach across the ecosystem to solve the challenges of patient access to innovative medicine at radically lower prices.

Kent Rogers Chief Customer Officer

EQRx believes responsibility can be revolutionary. Want to make a difference while advancing your career? Come join a team that is working towards our bold mission of developing innovative medicines at radically low prices to help people get the medicines they need.

What You’ll Do

The Director, Biologics Drug Product Development will play a critical and highly visible role within the company by leading the overall strategy and focus for our biologics team, and will drive all formulation development, drug product process development, process characterization, validation, and cGMP manufacturing activities necessary for BLA approval and commercial launch. As a key technical leader, you will play an instrumental role in establishing best practices for parenteral drug product development, scale up, technology transfer, and commercial manufacture at external CDMO manufacturing sites.

 

You will provide CMC leadership for the EQRx biologic drug portfolio, specifically in the areas of formulation development and parenteral drug delivery of monoclonal and bispecific antibodies. You will work closely with subject matter experts to select and engineer the appropriate parenteral delivery device for our wide array of biologic drugs. This position will interface with the Biologics Discovery team to progress molecules from pre-clinical to clinical stage, subsequently preparing the process and technology for commercial manufacture to ensure a successful BLA package. You will be responsible for establishing robust biologics drug product manufacturing processes and implementing control strategies in support of our pre-clinical, clinical development and commercial programs. You will oversee the development and scale up of biologics drug product manufacturing processes that meet quality requirements based upon quality by design (QBD) concepts that address critical quality attributes and process parameters.

You will contribute to and author relevant regulatory submission documents (pre-IND, IND, IB, BLA, etc.) and provide strategic guidance on regulatory interactions relating to biologics drug product manufacturing operations, process control strategy, process validation, specification setting and quality control. This role will work cross functionally and manage relationships with internal and external stakeholders. You will establish and maintain an understanding of current trends, emerging formulation and sterile manufacturing technologies, advanced drug delivery device systems, and ensure full awareness of current and emerging global capabilities for parenteral drug product manufacturing. An important requirement of this role is the ability to identify and leverage cutting-edge technologies that can significantly impact clinical drug development decisions and bring value to patients and prescribers. You will represent bioprocess development and biologics manufacturing at internal scientific reviews and governance meetings, external forums, consortia and health authority interactions. Build relationships & collaborate with scientific leaders, KOLs, academic partners, CROs, and health authorities.

The Impact You Will Have

This is not your standard Biologics Drug Product Development position. We are doing things different here than how it is normally done, and this role is no exception. This position is highly visible and of significant impact to the company. We are on a critical mission to bring quality solutions to patients at a fraction of the price. This role will help us drive forward towards that pinnacle goal of truly putting patients first.

Your Superpowers

  • You have an advanced degree, preferably a Ph.D., in Bio/chemical engineering, Pharmaceutical sciences or related life sciences discipline, with a minimum of 15+ years of bioprocess experience in an established biopharmaceutical organization.
  • You have demonstrated experience with successful IND and BLA drug submissions for monoclonal antibody drug products.
  • You have experience authoring CMC sections of global regulatory filings, especially for US BLA submissions.
  • You possess expert level knowledge and experience with biologics drug product development pre-formulation/formulation development, sterile fill and finish process development, process scale up for GMP manufacturing and technology transfer to external CDMO partners.
  • You have had prior experience in developing stable high-concentration, low viscosity formulations for subcutaneous delivery of monoclonal antibodies.
  • You have a deep and broad knowledge of CMC regulatory requirements from various health authorities, including the development of product specifications, process characterization and validation studies.
  • You have thorough knowledge of cGMPs for manufacture of biologic drugs, ICH guidelines and QBD principles Extensive drug product development experience preferably advancing several antibody drugs from preclinical stage through clinical development and approval and supporting post-marketing/commercial activities.
  • You have a detailed understanding of all stages of Late-Stage formulation development, including process design & characterization, process control strategy and Process Performance Qualification (PPQ).
  • You have a demonstrated track record of CDMO management of technical activities and analysis/interpretation of results to support biologic drug product manufacturing process development, tech transfer, optimization, characterization, qualification and GMP manufacturing.
  • You have proven experience in building a high performing team. You can recruit and develop top talent, motivate, and empower a team, work cross-functionally, and delegate effectively.
  • You understand relationships are key and have strong interpersonal skills.
  • Teams love working with you and you are someone who takes pride in mentoring and supporting the careers of others.
  • You can thrive in a smaller company environment and love the pace of a true startup.
  • You’re a team player who is willing to roll-up your sleeves and get the job done.

Are you bold enough?

Your work should matter and allow you the freedom to be 100% you. We spend too much time and effort in our career to not feel excited and proud about what we do and who we do it with. In other words, your career is too important for your next move to be just another job, so let’s work together to change the world and bring affordable medicines to all patients.

We aren’t about a bunch of empty slogans on a wall or words on a coffee cup – you can find that in lots of places. We are a culture of individuals with diverse backgrounds and personalities. What does EQRx stand for? 

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Are you bold enough?

Your work should matter and allow you the freedom to be 100% you. We spend too much time and effort in our career to not feel excited and proud about what we do and who we do it with. In other words, your career is too important for your next move to be just another job, so let’s work together to change the world and bring affordable medicines to all patients.

We aren’t about a bunch of empty slogans on a wall or words on a coffee cup – you can find that in lots of places. We are a culture of individuals with diverse backgrounds and personalities.

The Disruptor

Are you ready to make waves in the industry and change the tides?

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  • Attribute Thumbnail: Vision Vision
  • Attribute Thumbnail: Collaboration Collaboration
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What does EQRx stand for?

  • EQuality Medicines: Equally good or better, innovative medicines
  • EQuitable Medicines: Making innovative medicines affordable
  • EQual Access: Sustainable, frictionless access for people to cutting-edge medicines

We have a bold mission and are looking for equally bold people who want to join us and help make a difference in the world. If you want to grease the wheel we are definitely not for you. Want to build the wheel? We might be just what you are looking for.

EQRx is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

It’s (mutually) beneficial.

You’re curious about what sets us apart from the rest. What do you get from working at EQRx?

So, let’s start big—working at EQRx means having the opportunity to change the world.

By joining a team that’s remaking medicine development from start to finish, you’re going to enjoy the daily rush of throwing caution to the wind and doing things differently by:

  • Working with the smartest game-changers in the industry
  • Cutting down the red tape of “the way things are done”
  • Seeing and feeling the daily impact of your work
  • Growing as a professional and a person
  • Committing to neverending social responsibility

And, yes—we also have a killer list of things that’ll help you shine as part of the team.

But to us, these are just table stakes.

  • 100% Medical, Dental, and Vision coverage
  • Flexible Spending Account
  • Health Reimbursement Account
  • Free snacks and drinks

*As EQRx grows, please note that some of these are subject to change.

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