Senior Director/Director, Cmc -Leadership Role Within Company Product Development/Cmc

Company Description
Corbus Culture:
Corbus is a close-knit team of high-achieving, innovative, creative and, above all else, passionate employees. We hire for personality as well as for skill. At Corbus, we take pride in our "family" atmosphere where each person's contribution is vital to our success. As a Corbus employee, you are empowered to think creatively and be proactive in your approach. There is no place for politics or red tape here.
About Corbus
Corbus is a precision oncology company committed to helping people defeat serious illness by bringing innovative scientific approaches to well understood biological pathways. Corbus' internal development pipeline includes CRB-701, a next generation antibody drug conjugate (ADC) that targets the expression of Nectin 4-on cancer cells to release a cytotoxic payload and CRB-601, and anti-integrin monoclonal antibody which blocks the activation of TGFβ expressed on cancer cells. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on Twitter, LinkedIn and Facebook.
Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer
Job Description
Corbus Pharmaceuticals is recruiting for an exciting Leadership role to drive development of Corbus' biologics programs. As CMC lead and a key member of the Product Development Team (PDT), you will be contributing and defining CMC strategy, budget, and key deliverables to integrated product development plans and you will be accountable for delivering on approved plans. You will foster on your vast experience and provide expertise comprising of early to late-stage antibody product development including new product development, technology transfer, analytical method development and manufacturing. You will contract, manage, and oversee all manufacturing activities of company products outsourced to CDMOs. In accordance with company plans and timelines you will build up and lead a company internal CMC team as well as contract and manage CMC matter experts/consultants as needed.
Your leadership will include CMC regulatory (IND writing, maintenance, and regulatory submissions) to advance the product portfolio of Corbus pharmaceuticals. You have a hands-on attitude, willing to take responsibility and accountability and drive decision making in a striving and growing Biotech environment. You like to interact cross-functionally and lead by example.
Responsibilities include, but are not limited to

• Lead CMC activities in support of protein therapeutic products with full budget, resources, and headcount responsibility for CMC
• Define CMC product development strategy and implementation plans for company products.
• Lead DS and DP manufacturing activities and pharmaceutical development (including draft, review and approve technical documentation) and collaborating with Clinical Operations to manage clinical supplies activities such as labelling, distribution etc.

• Select CMOs/CROs involved with the program, build, and maintain strong relationships. May include some (minor) travel to assist in CMO selection, auditing, and oversight.
• Manage contracts and budget of CMC vendors, and ensure timelines are well integrated with program goals.
• Apply a science and risk-based approach for addressing deviations, conducting thorough investigations in conjunction with GMP Quality Assurance, and putting in place corrective actions/preventive actions (CAPAs)
• Head the review/preparation of regulatory CMC submissions [e.g. Investigational Medicinal Product Dossier (IMPD), INDs] and represent Corbus at meetings with Regulatory Agencies with reference to CMC.
• Work within/lead Corbus Manufacturing Sub-Team. Contribute with clear communication to cross-functional teams. Serve as core member of the Corbus Product Development Team, representing the CMC function and aligning on priorities.
• Partner with Quality, clinical operations and Regulatory to ensure timelines, deliverables, and business obligations are aligned and met.

Qualifications
Knowledge and Skills:

• Ph.D in Biochemistry, Chemical Engineering, Biotechnology, Pharmaceutical Sciences or equivalent is preferred
• Expertise in cGMP manufacturing, CMC regulatory and related requirements for biopharmaceuticals (DS upstream and downstream, DP aseptic fill finish, IMP packaging/labelling for clinical supplies)
• Must have 10+ years of pharmaceutical CMC strategic product development experience, to include pre-clinical/clinical setup of manufacturing, process development, scale up, process validation.
• Clear understanding of requirements and expertise in delivering IND and BLA CMC packages and advancing processes through clinical development and ideally through to commercialization.
• Mastery of scientific and engineering principles
• Demonstrated ability to influence novel CMC and regulatory pathways to accelerate development.
• Experience of representing CMC at meetings with regulators
• Ability to think critically, and demonstrated troubleshooting and problem-solving skills
• Excellent interpersonal, verbal, and written communication skills
• Self-motivated and goal focused.

Additional Information
All your information will be kept confidential according to EEO guidelines.