Associate Director of Upstream Development Job at Kelly
Kelly Scientific is searching for an
Associate Director, Upstream Development to support a leading cell and gene therapy CDMO.
They occupy a GMP facility of 15,000 sf. including isolated labs for cell culture, fermentation, purification and analytical services.
Location: Southborough, Massachusetts
Salary: Commensurate with experience
Summary: The Associate Director of Upstream Development will lead a team of upstream scientists and associates to develop upstream processes for biologics drug substances and support subsequent clinical and/or commercial GMP manufacturing.
Responsibilities:
Qualifications:
They occupy a GMP facility of 15,000 sf. including isolated labs for cell culture, fermentation, purification and analytical services.
Location: Southborough, Massachusetts
Salary: Commensurate with experience
Summary: The Associate Director of Upstream Development will lead a team of upstream scientists and associates to develop upstream processes for biologics drug substances and support subsequent clinical and/or commercial GMP manufacturing.
Responsibilities:
- Provide technical expertise and leadership in planning, designing, and conducting experiments, analyzing data and documenting results towards development and optimization upstream processes and/or achieving goals for cross functional development teams.
- Manage process/technology transfer (externally from client or internally to Manufacturing) and provide manufacturing support and troubleshooting.
- Support IND/BLA CMC purification process document preparation.
- Direct upstream innovation projects, new technology evaluation/ implementation, as well as conference presentation and journal publication.
- Contribute to department and corporate strategic planning and objectives setting.
- Mentor team members and manage department budget.
- Provide technical support to business and sales team and represent upstream development functions in client meeting.
- Author SOPs, protocols and technical reports and ensure adherence to high technical standards and compliance with applicable regulatory guidelines.
- Maintain accurate experimental records and results in laboratory notebook and/or datasheet.
- Manage resource planning and projects with excellent financial, timing, and priority awareness.
Qualifications:
- Ph.D./MS/BS degrees in biology, biochemistry, biomedical/biochemical engineering, or related fields
- Ph.D. with 10 yrs, MS with 12 yrs or BS with 15 yrs experience in upstream bioprocess related process development, scale-up and tech transfer to cGMP manufacturing facility in biotechnology, pharmaceutical or related environment; Proven record of technical leadership
- Excellent and extensive knowledge/experience of cGMP working environment
- Excellent technical, organizational, and communication skills, as well as the strong ability to develop creative solutions to challenging problems
- Proven strong ability to work in a fast-paced environment with demonstrated capacity to juggle multiple competing tasks and demands
- Proven strong judging ability when a decision-making is needed during the execution of a project
- Outstanding teamwork/collaboration spirits and excellent ability to communicate appropriately and effectively
- Excellent strategic views in judging business trends & their potential impacts, and proactive attitude to learn new technologies and manage changes in process development and process scale-up
- Proven excellent management experience and leadership aptitude, and excellent financial awareness
- Client focused, quality, results, productivity, and efficiency oriented, and science and innovation driven
- Advanced written skills
- Attention to detail, and the ability to multitask
- Proficient with the use of MS Office software(MS Excel, MS Word, MS Powerpoint) and statistical DOE software including JMP, Minitab, Design Expert etc.)
- Flexible and results oriented
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