DirectorSr Director CMC
DirectorSr Director CMC
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Job Description
Sr. Director/Director CMC
Company Overview:
Mythic Therapeutics is a privately held clinical stage 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 ADC uptake in tumor cells with less impact on healthy cells thereby safely increasing efficacy 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 seeking a Sr. Director/Director Chemistry Manufacturing and Control (CMC) to lead the technical development and delivery of scalable robust manufacturing processes and analytical methods for our ADC drug candidates including development of integrated control strategies and implementation of technologies to support continued innovation. The incumbent will have significant interactions and collaboration within the company and with external CDMOs CROs and other industrial partners. He/she will play a central role in bringing the companys pipeline of products to the clinic.
The Director CMC will report to the VP Technical Operations and be a key member of the Technical Operations function leadership engaging with internal and external technical experts to assure development and manufacturing execution for Mab ADC drug substance and drug product. As a member of the Product Development Team the candidate will engage with crossfunctional leadership to define and execute program strategy in alignment with Executive Leadership and Company objectives. The ideal candidate for this role is an individual who has significant CMC/technical development/external manufacturing management experience particularly in the area of ADC drug development. He/she will be excited to take on new challenges in an agile and entrepreneurial environment.
Day to Day Responsibilities and Opportunities:
- Lead the technical development scaleup and technology transfer of ADC manufacturing processes to support the companys development programs from candidate optimization/selection through preclinical development and clinical development. This will include guiding all CMC technical development including cell line development both upstream and downstream antibody process development conjugation process development formulation and drug product development and process analytics (including data management).
- Managing programfocused oversight of a network of CDMO and CRO partners as well as suppliers and vendors to deliver expedited CMC development external supply reliability and flexibility and product quality. Maintain highly collaborative partnerships while providing robust oversight of technical development scaleup technology transfer and manufacturing activities across the supply network.
- Apply QualitybyDesign principles to develop robust scalable manufacturing process technologies and process analytics; build a deep understanding of the ADC manufacturing process platform (CQAs CPPs etc) and lead the development of effective operational control strategies.
- Support regulatory strategy and activities including authoring and reviewing relevant sections of global regulatory filings as appropriate
Additional Responsibilities
- Leverage scientific/technical experience and project/program management skills to help advance Mythics development programs from discovery to clinical development with an eye toward commercial readiness.
Required Qualifications and Skills
- A PhD or MSc in relevant life sciences or engineering field with at least 7 years (with a PhD) or 10 years (with an MSc) leadership experience in bioprocess analytical or bioanalytical development or related areas.
- Proven experience in managing outsourced CDMO manufacturing process development or analytical development functions involving complex biological processes including tech transfer; experience developing ADC manufacturing processes is a plus
- Inpractice knowledge of relevant global regulatory requirements
- Strong interpersonal skills with the ability to motivate others influence and negotiate conflict situations
- Outstanding communication analytical and organizational skills
- Is recognized as a thought leader within peer communities
- Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
- Ability to navigate and be successful in a dynamic fastpaced entrepreneurial environment
- A passion for addressing the critical unmet medical needs of patients
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.
- 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.
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.
Mythic Therapeutics is an equal opportunity employer. We do not discriminate on the basis of race color gender gender identity sexual orientation age religion national or ethnic origin disability protected veteran status or any other basis protected by applicable law. Mythic does not accept unsolicited resumes from any source other than directly from candidates.
Employment Type
Full Time
