Overview

POSITION SUMMARY:

Under the general direction of the Director or designee, the Associate Director, Technology - Nucleic Acids will lead the process development and manufacturing technical support for GMP oligonucleotide manufacturing activities. The Associate Director, Technology – Nucleic Acids will oversee the development and implementation of new processes and procedures for the manufacture of different classes of nucleic acids. This position will work closely with analytical and manufacturing groups.

Responsibilities

ESSENTIAL FUNCTIONS:

Manage overall process development and technology transfer of nucleic acid products in accordance with Food and Drug Administration (FDA) guidelines and Good Manufacturing Practices (GMP).
Oversee the design and scale-up of processes and equipment used to perform the process development, manufacturing technical support and manufacturing functions.
Develop new technologies for the production of nucleic acids
Participate in the development of the operations budget including capital requirements.
Develop the strategy for process design, optimization, scale-up, technology transfer and process troubleshooting to meet project timelines and company goals.
Participate in hiring, developing and managing staff.
Provide guidance and direction to staff; establishing expectations, defining roles, supporting career development and managing performance.
Oversee the technology transfer and optimization of the manufacturing process, assuring compliance with GMP and FDA regulations.
Prepare written documentation as necessary to facilitate transfer of manufacturing process to manufacturing groups and to inform senior staff of project progress and issues that may arise.
Coordinate Internal and external development and manufacturing programs for nucleic acids
Collaborate with external vendors for the evaluation and adaptation of new technologies
Publish scientific articles and present results in national and international meetings.
Other duties and/or projects as assigned.

Qualifications

REQUIRED QUALIFICATIONS:

Requires a PhD in a relevant scientific discipline such as Organic Chemistry, Analytical Chemistry, Biochemistry, Chemical Engineering, and a minimum of 5-7 years of relevant experience (including management experience) or equivalent. Experience in a cGMP environment is required
Experience in one or more of the following areas is required:
- Developing methods for HPLC, Mass Spectrometer and other analytical instruments as well as assay development experience
- Experience with Hi-Res tandem Mass Spectrometry and oligonucleotide synthesizer
- Solid knowledge in the principles of biochemical and biophysical analytical techniques for nucleic acid characterization.
Experience in chemistry of nucleosides and nucleotides, nucleic acid modifications, and purification of oligonucleotides are highly desirable.
Demonstrated technical proficiency, scientific creativity, collaboration with others, and independent thought. Solid knowledge on scientific principles and concepts.
Prior experience with nucleic acid products manufacturing. Must have strong verbal and written communication skills. Ability to communicate effectively with others internally (up, down, and laterally) and externally to the organization.
Demonstrated ability to manage and prioritize multiple projects and consistently meet deadlines.
Possesses strong attention to detail, ability to maintain accurate records and excellent proofreading skills
Excellent problem-solving skills as well as time management and organizational skills.
Capabilities to manage others, assign and schedule work, and conduct performance evaluations.
Occasional travel is required.
Ability for flexible working hours to meet business needs.

Additional Information

*LI-CH

University of Massachusetts Medical School

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Associate Director Manufacturing, Process Development – Nucleic Acids