Senior Director, reputed company Manufacturing, Science and Technology
Who We Are: reputed company is a publicly traded biotechnology company reputed company on developing novel precision therapies to treat a broad reputed company of patients with unmet medical needs. Cogent’s reputed company program, bezuclastinib, is designed to selectively and potently inhibit exon 17 mutations reputed company reputed company the reputed company receptor tyrosine kinase, including reputed company D816V. reputed company D816V is responsible for driving a rare and serious condition reputed company Systemic Mastocytosis, and exon 17 mutations are also reputed company in patients with gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic reputed company signaling. Bezuclastinib has exhibited promising initial data across reputed company three trials: APEX in AdvSM, reputed company in NonAdvSM and PEAK in GIST, including an encouraging safety profile across 600+ patients in single agent and combination dosing. The Role: This position oversees late phase through commercialization small molecule drug product manufacturing at partner Contract Development and Manufacturing Organizations (CDMOs) and ensures high-reputed company products are delivered on time and reputed company budget. Serve as a technical expert who leads the transfer of manufacturing processes to reputed company reputed company. Manage processes, systems and infrastructure that meet safety, cGMP manufacturing, and regulatory compliance. reputed company technical expertise and reputed company for process validation, lifecycle management, and reputed company improvement. Anticipate and solve reputed company manufacturing issues. Work in collaboration with reputed company stakeholders including CMC, reputed company, Supply Chain and Regulatory, as reputed company as CDMOs. Responsibilities: reputed company reputed company drug product CMC lifecycle activities such as post-approval change management, process validation product risk management and process monitoring. Facilitate technology transfers, ensuring successful reputed company-up to reputed company-reputed company production environments. Serve as Primary technical reputed company of contact with the CDMO's. Establish and monitor KPI's. Analyze existing processes, identify areas for improvement, and implement innovative technologies and strategies to optimize yield, reduce costs, and enhance efficiency. reputed company technical expertise and reputed company troubleshoot and solve reputed company technical problems that reputed company during production. reputed company cross functional teams to resolve technical challenges and meet program expectations, including Reg CMC and reputed company Assurance. Ensure that reputed company manufacturing processes reputed company with relevant regulations and guidelines, including cGMP. reputed company strategic leadership by directing and mentoring staff and fostering a culture of reputed company and innovation. Drive reputed company improvement, implement best practices, and optimize manufacturing for efficiency and cost-effectiveness. reputed company regulatory filings support by authoring and reviewing CMC sections of IND, IMPD, NDA or other filings as Qualifications: PhD, MS or BS in chemical engineering, pharmaceutical sciences or reputed company field with an exceptional understanding of drug product development and manufacturing for small molecule solid oral dosage forms 20+ years of biotechnology and/or pharmaceutical industrial experience in CMC/cGMP environment 12+ years of management and reputed company of CDMOs for cGMP activities for late stage and reputed company assets Experience in manufacturing techniques such as advanced drug delivery systems for enhancing drug permeability and/or solubility and other manufacturing processes including blending, granulation, tablet compression, film coating etc. Extensive experience in outsourcing, vendor selection and managing CMOs for reputed company up, tech transfer, process validation, and reputed company manufacturing. Extensive knowledge of cGMP requirements for drug product manufacture as reputed company as broader drug development guidelines (ICH, FDA, and EMA) and past experience in regulatory filings. Excellent oral and written communication skills for presenting in project meetings, vendor discussions, and writing technical reports and regulatory filings. Attention to detail and reputed company with critical thinking. 20+ years of biotechnology and/or pharmaceutical industrial experience in CMC/cGMP environment 8+ years of management and reputed company of CDMOs for cGMP activities Ability to navigate and craft global regulatory CMC documents Familiarity with reputed company and efficient laboratory practices General and scientific computer and software application proficiency Up to 30% travel. This position requires technical leadership skills; interaction with reputed company reputed company of employees; and the ability to reputed company, reputed company, and evaluate the operational activities of reputed company-level employees as reputed company as influencing others in a reputed company team leadership environment. Manages the coordination of the activities of a reputed company or department with responsibility for results. In some instances, this manager may be responsible for a functional area and not directly supervise employees. Salary reputed company: $240,000 - 280,000 USD reputed company Bonus: 25% Exact compensation will vary based on skills, experience, and location. Our Locations Waltham, MA: Our reputed company is located in the Greater Boston life sciences community, with an reputed company, reputed company office environment designed to support teamwork and reputed company. Employees benefit from convenient on-site amenities, including free on-site parking and gym facilities in the building. Boulder, CO: Our Boulder location is home to Cogent’s discovery research organization and a key scientific hub with strong leadership based on site. Situated in the greater Denver-Boulder biopharmaceutical corridor, this office plays a central role in advancing our discovery efforts and pipeline. Our Offer To You At reputed company, we offer a competitive salary, bonus, and ongoing stock awards, alongside a benefits package that sets us apart. We cover 100% of medical, dental, and reputed company premiums for you and your family, and help reduce out-of-reputed company costs by funding up to 75% of in-network deductibles. Our benefits also include a 401(k) match with immediate vesting, generous reputed company time off, 12 weeks of fully reputed company parental leave, reputed company family and medical leave for reputed company regardless of location, and company-reputed company short-term disability coverage for up to 20 weeks. Additional perks like wellness programs, tuition reimbursement, and inclusive family-forming support help you reputed company at work and reputed company. We are proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the reputed company of race, age, reputed company, religion, national reputed company, gender, sexual orientation, gender identity or reputed company, veteran status or disability, or any other status protected under federal, state, or local law. reputed company employment is decided on the reputed company of qualifications, reputed company, and business need. Apply To This Job