The Director, Process Development and Manufacturing will lead the process chemistry and development for drug substance (API) spanning from discovery leads to support commercial production. The responsibilities include process development for new molecules and corresponding regulatory intermediates, identify CMOs to manufacture the APIs, carry out technology transfer to CMOs and manufacturing API following cGMP to meet portfolio needs, conduct scale up and technology transfer to support commercial supply needs. The individual will also be responsible for defining comprehensive control strategy to ensure quality API in a risk-based and phase appropriate manner, authoring drug substance CTD sections to support regulatory submission during clinical development and global registration and addressing health authority questions working with cross-functional team. He/She will provide strategic direction, tactical oversight and technical expertise for all activities within the Process Development and Manufacturing function. The individual must have proven supervisory record and can work effectively at operational and governance levels in a fast-paced environment. Strong initiative and follow through are essential for this job. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.
Essential Duties and Responsibilities
- Responsible for process development and manufacturing of drug substance (API), GMP starting materials and intermediates to enable clinical material manufacturing and process knowledge acquisition.
- Provide technical support for commercial production and responsible for technical transfer or scale up to ensure commercial supply.
- Delivery high-quality API requirements on time by applying a science-driven and risk-based API process development strategy
- Devise novel solutions and strategies to complex synthetic problems
- Identify and communicate risks and implement effective mitigation strategies by applying knowledge in process chemistry and overall drug development
- Have knowledge of GMP regulations, ICH guidance and current regulatory expectations
- Acquire key capabilities to support Myovant portfolio and products using innovative technologies
- Manage process budgetary, regulatory, and compliance systems within the framework of an internal and outsourced development and manufacturing business model.
- Continue to establish a comprehensive knowledge management system to capture critical raw data, process development activities, knowledge and to manage change control and regulatory submission
- Review, and/or approve Standard Operating Procedures, synthetic routes, regulatory filing, or other controlled documents as needed
- Serve on Pharmaceutical Operations & Development leadership team as well as cross-functional governance committee for organizational and technical decisions
- Participate in due diligence business development activities
- Perform other duties as assigned.
Core Competencies, Knowledge, and Skill Requirements
- Thorough understanding of the product development and process development for late-stage clinical projects
- Proven track record of significant accomplishment in Process Development, including API production, GMP compliance, problem solving, novel idea generation and implementation and multi-step synthesis of complex molecular architecture
- Ability to prioritize, manage multiple tasks, and meet deadlines
- Ability to interpret and apply ICH guidance, cGMPs, USP, regulatory requirements and industry best practices
- Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required.
- Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction.
- Daily demonstrates a positive, ‘can do’ and service oriented attitude. Strong oral and written communicator; detail-oriented with a commitment to accuracy.
- Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks.
- Ability to multi-task and shift priorities quickly while working under tight deadlines.
- Skilled in developing collaborative internal and external relationships.
- Required skill in the operation of standard office equipment including: fax machines, copy machines and other equipment as necessary.
- Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
- Excellent verbal and written communication skills, as the position will interface potentially key opinion leaders, employees and external partners
- Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company.
- Routinely interface with other functional areas, such as Analytical Development/ Quality Control, Pharmaceutical Technology, Quality Assurance, Regulatory, Supply Chain, Contract Manufacturing and external partners in a collaborative and effective manner
- Become a member of leadership team for Pharmaceutical Development & Manufacturing and participate in strategic decisions relating to project, organization, processes, budget and culture within the department
- Doctorate degree from a leading institute in Synthetic Organic Chemistry, Chemical Engineering, Process Chemistry and related fields.
- Requires 10+ years of progressive experience in the biopharmaceutical/biotech industry, GMP environment.
- Deep knowledge of modern process chemistry, process development, and practical experience with synthetic process development meeting safety, efficiency and environmental requirements, solid scientific knowledge of process chemistry, engineering and scale up
- A good understanding of the drug development process.
- Significant experience working in an outsourcing environment to support both clinical and commercial demand
- A strong track record of scientific achievements and effective ability to influence
- Candidates should have advanced problem solving skills, strategic thinking, process optimization experience and outstanding written and verbal communication skills
- Managerial responsibility of a small team.