Dir./Sr. Manager, Biopharmaceutical Development (CMC)

BioSpace has been engaged to help our Austin, TX client, a clinical stage biopharmaceutical company focused on the discovery and development of differentiated, targeted, biologic therapeutics for cancer hire a Director or Senior Manager for their Biopharmaceutical Development team. 

Position Overview:

Our client is seeking a highly experienced and dynamic professional to oversee and direct chemistry, manufacturing, and controls (CMC) development and manufacturing strategies for new and mature products. This Director or Sr. Manager will provide guidance and support to internal groups such as process and product development, quality, manufacturing, supply chain and regulatory affairs, as well as to outside groups, such as contract manufacturing organizations and contract laboratories to ensure that products are manufactured in compliance with all applicable regulations and protocols. Additionally, this role will be responsible for providing strategic input and risk assessments and oversee preparation of CMC regulatory submissions. This position will require excellent technical, analytical and problem-solving skills, along with ability to operate independently and to collaborate with cross-functional teams, contractors and external regulatory agencies. 

Job Responsibilities will include:

• Participate in identifying, creating, and sustaining CMC processes to successfully support the growing pipeline of product candidates
• Oversee Operations functions within CMC, including but not limited to defining specifications, trending and analyzing batch data, maintain internal and external CMC documents, and supporting and defining aspects of distribution and release management
• Work within CMC and process development functions to help generate manufacturing summary reports to inform product, process, and analytical development and help identify and monitor product yields and/or product quality
• Compile, review and approve high-quality CMC modules for development and marketing registration applications, annual reports, amendments, and supplements for submission, ensuring complete CMC content that meets current regional requirements and FDA/Health Authority questions
• Manage efforts at contract service providers to support drug substance and drug product manufacturing, and development efforts as needed
• Manage and ensure compliance with all reporting requirements, including annual and periodic reports
• Assess and communicate CMC requirements to ensure all development activities are compliant with applicable regulations and guidelines
• Develop and distribute periodic reports on performance, issues, risks, and schedules of key activities, events, or milestones
• Serve as a CMC project contact with external and internal clients, as needed
• Support the review of CMC content for accuracy, including data verification, clarity, consistency, and conformance to writing conventions, and present findings to management
• Identify project issues and contribute to the development of alternative CMC development strategies

Qualifications:

• Advanced degree in the Life Sciences or related field, required
• Minimum of six (6) years of relevant experience in pharmaceutical, biotechnology or a related industry focused on drug development
• Demonstrated experience with large molecule biologics and minimum two (2) years directly involved with CMC operation efforts
• Experience in process or analytical development, qualification, and validation strategies, preferred
• Excellent written and verbal communication skills
• Excellent computer skills
• Excellent analytical skills and problem-solving skills
• Ability to manage competing priorities and timelines in a fast-paced, rapid-growth environment
• Ability to work collaboratively with cross-functional teams and contractors to drive results and meet company objectives
• Ability to function independently and exercise good judgement, as well as in a team-based environment
• Minimal travel required