CMC Project Manager

PlateletBio

Watertown, MA, US
  • Job Type: Full-Time
  • Function: Engineering Prod Mgmt/Dev
  • Post Date: 03/01/2021
  • Website: www.plateletbio.com
  • Company Address: 65 Grove Street, Suite 303, Watertown, MA, 02472

About PlateletBio

PlateletBio is the only allogeneic cell therapy company focused on platelet biology. We are pioneers, discovering a completely new category in therapeutics. Our approach is one-of-a-kind, recreating nature’s legendary delivery cell. In doing so, we’re developing a superior cell therapy empowered to tackle previously unmet medical challenges.

Job Description

This is your opportunity to join a highly driven and ambitious young company that values collaboration, respect, intellectual curiosity, and integrity in our endeavor to transform the way cell therapies are developed and to expand the field of platelet-derived therapeutics. Inspired by platelet biology, we have developed a scalable, cGMP-compliant cell culture platform to make engineered human pluripotent stem cell-derived megakaryocytes and platelets. This is an exciting time to join PB as we further scale production for human clinical trials and leverage our platform for cell-based drug delivery opportunities. 

Our Ideal Candidate

We are looking for an exceptional Project Manager with deep experience in CMC (Chemistry, Manufacturing and Controls) to join our fast-growing team.  In this new role, this individual will be a key influencer and leader at PlateletBio, partnering with leaders throughout the organization to drive the delivery of product development projects.  Reporting directly to our VP of Program and Alliance Management, this position will work collaboratively with functional area leads and their program teams to plan, track and report the diverse activities managed by the Manufacturing Sciences team.  We are looking for someone with an entrepreneurial spirit that will embrace this newly created role on a small team as we prepare for Phase I clinical trials. 

The successful candidate will be detail-driven and have a proven track record in managing and driving project success within CMC in the Life Sciences industry, preferably with cell or gene therapy programs. We are seeking an individual with a collaborative approach to their work, with demonstrated emotional intelligence, and the willingness to lead the team through a pivot when priorities change.

Key Responsibilities

Specifically, this individual will be responsible for:

  • Planning and executing the IND enabling activities for our programs across the CMC organization.
  • Coordinating all the drug product supply needs across the organization (CMC and R&D) and planning with the manufacturing organization to meet those needs.
  • Planning and executing for scale up needs with the manufacturing organization for future development needs.
  • Tracking and monitoring key milestones and decision points to drive the delivery of project objectives.
  • Effectively communicating with team members, senior leaders and key stakeholders on the status, objectives, risks, and mitigation plans associated with projects.
  • Facilitating CMC budgeting, forecasting, and long-range planning activities for all programs.

Preferred Skills and Qualifications

  • Bachelor’s degree in life sciences or related field. Advanced degree (MS, PhD or MBA) and/or PMP Certification preferred.
  • A minimum of 7-9+ years of experience in the biopharmaceutical/pharmaceutical industry. Previous experience in cell therapy or gene therapy preferred.
  • A minimum of 3+ years of experience in CMC project management of clinical pharmaceutical products across the entire product development timeline, including demonstrated planning, organization, change control and risk mitigation skills.
  • Strong verbal and written communication skills including documentation and document editing.
  • Strong leadership skills, including demonstrated ability to lead a cross-functional team, and to influence at all levels of an organization.
  • Ability to analyze and solve technical and organizational issues.
  • Excellent problem solving and creative skills, combined with the ability to exercise sound judgment and make decisions based on accurate and timely analyses.
  • Ability to learn and adapt in a fast-paced and dynamic work environment.
  • High level of integrity and dependability, with a strong sense of urgency and results-orientation.

 

The Company

Platelet Bio, located in Watertown, MA, is a venture-backed biotech startup that was spun out of Harvard Medical School to produce allogeneic cell therapies from engineered induced pluripotent stem cells (iPSCs).
 
As an equal opportunity employer, Platelet Bio does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin or veteran status.  We value diversity and are committed to creating an inclusive environment for team members from all backgrounds.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.