Associate Director / Director, Quality Control
Associate Director / Director, Quality Control
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1 Vacancy
Job Description
Company Overview:
Mythic Therapeutics is a privately held productplatform company building a pipeline of bestinclass antibody drug conjugates (ADCs) exhibiting a combination of unprecedented efficacy and therapeutic index. The Companys FateControl engineering technology dramatically enhances tumor uptake of ADC per dose thereby safely increasing potency and opening up new therapeutic opportunities against a broad array of tumor targets.
At Mythic Therapeutics we approach our work as entrepreneurs and innovators blazing new trails that lead to better patient outcomes. We do so decisively and thoughtfully drawing upon the decades of experience within our leadership team and scientific advisers. If you share our passion and sense of urgency for developing effective cancer treatment options and are looking for a dynamic collaborative and fulfilling work environment we invite you to explore opportunities to join our team. Together we are reenvisioning cancer therapy.
Job Summary:
Mythic Therapeutics is searching for a dynamic AD/Director Quality Control to join our growing Quality team.
The AD/Director Quality Control will be responsible for ensuring analytical methods are appropriately qualified and/or validated. Specifications are managed and appropriately set to support the release of clinical and commercial material. Managing the Stability Program for intermediate Drug Substance and Drug Product for clinical and intended commercial material. The successful candidate will have a proven track record and handson experience building phase appropriate quality systems and a demonstrated ability to work in an entrepreneurial environment in a transitional development environment and understands the requirements for managing analytical methods/QC release tests for latestage programs. They will possess a cando executionoriented mindset. This position will report directly to the VP of Quality.
Key Responsibilities and Opportunities:
As a key member of the Quality Team at Mythic Therapeutics you will:
- Work effectively to establish a relationship with the CMC focused internal and external stakeholders
- Work effectively to establish a relationship with and to perform appropriate oversight of Mythic CMOs and CTLs as it related to QC functions and responsibilities
- Work crossfunctionally to further develop implement and improve the Quality Control procedures and Quality Control oversight.
- Review Intermediate Drug Substance and Drug Product lot related analytical results and generate Mythic certificate of analysis in support of lot disposition for each material.
- Manage the Stability Program for Intermediates Drug Substance and Drug Product. Review stability data provide interim stability and final stability report and manage the process of extending expiration dates based on stability data.
- Work with CMO/CTL to resolve any Quality Events related to analytical testing of lots to enable disposition.
- Work within the Quality QMS system and initiate and/or support any Quality events and/or change controls related to analytical testing.
- Evaluate and propose appropriate QC focused quality systems to enhance and incorporate into Mythics Quality Management System.
- Nurture a strong riskbased quality compliance culture within Mythic.
- Write and review Quality Control focused SOPs protocols and reports.
- Review and revise as applicable the IND and IMPD CMC sections as it related to analytical methods specifications and stability.
- Lead preparations for regulatory inspections and ensure inspection readiness as it relates to Quality Control at Mythic.
- Keep up to date with all related analytical/quality control related regulations and guidance as well as relevant industry and best practices.
Minimum Requirements
- Bachelors degree in a science discipline (Biology Chemistry Biochemistry or similar) with at least 10 years of Quality Control/Analytical experience in the Biotech/Pharmaceutical Industry; at least 5 years of experience as lead QC.
- Thorough knowledge of all facets of GxP regulations ICH guidelines and industry standards
- Ability to work cross functionally in a team environment
- Proven skills and track record of leading and developing Quality Control function within the pharmaceutical or biotechnology industry
- Extensive experience with biological manufacturing and testing
- Experience with ADCs a plus
- Ability to deliver under tight timelines
Personal Characteristics and Cultural Fit:
- Good judgement: Strong problem solving critical thinking and analytical skills required to make evidencebased decisions. Good judgment levelheaded neutral and objective.
- Builds Relationships and Culture: Reputation for creating strong team cultures of quality trust and collaboration. Skilled at building and managing relationships crossfunctionally and with external collaborators/partners consultants and vendors.
- Excellent written and oral communication skills
- Influences: Highly credible with various stakeholder group (internal employees updown and across the organization external collaborators partners and vendors and with site teams and investigators). Skilled at building and cultivating stakeholder confidence
- Execution mindset: Selfstarter with a cando mindset and do what is needed to advance the companys programs and initiatives. Drives self individual and team accountability develops and implements goals objectives measurable targets and processes to achieve results.
- Demonstrated ability to work in a fastpaced innovative biotech environment.
Location
Highly preferable to be based in the Boston area or willing to relocate. This is a hybrid position 3 days in the office and 2 days remote
Mythic Therapeutics offers a fastpaced entrepreneurial teamfocused work environment. We also offer a topnotch benefits package and work/life integration. Being part of the Mythic team allows you to become part of a small team that supports professional development while working together to meet the company goals.
Employment Type
Full Time
