Manufacturing Technician I Job Summary
- We are seeking a Manufacturing Associate position based at to our new GMP Manufacturing site in Norwood, MA.
- The individual in this role will be part of a cohesive team responsible for enabling production of high quality mRNA-based medicines for evaluation in human clinical trials. The candidate will apply existing and new knowledge of laboratory unit operations and cGMPs to enable technical success with stringent adherence to a Quality System that respects global regulatory expectations. As part of the Manufacturing Support Team, the individual is responsible for buffer and material preparation, weigh and dispense, and equipment preparation operations (autoclave and glass wash).
- The successful candidate will be able to document and communicate their technical and operational observations clearly and efficiently. They will be able to operate pilot-scale bio-processing equipment and interact fluidly with peers and supervisors in the Pilot Plant, and cross-functionally with Quality Control, Quality Assurance, Logistical, and Process Development technology transfer counterparts.
Education & Qualifications
- Be a consistent contributor, under the guidance of a shift leader.
- Demonstrate general knowledge of standard laboratory practices and equipment.
- Strict adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation. Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data.
- Monitor process operations to ensure compliance with specifications.
- Complete tasks in support of large scale manufacturing, including in the care of high-value capital equipment
- Assist in the investigation of procedural deviations.
- Practice safe work habits and adhere to the safety procedures and guidelines.
- Utilize knowledge to improve operational efficiency.
- Adhere to Pilot Plant gowning procedures and maintain a clean general operating area.
- Adhere to documented waste handling procedures to respect environmental regulations.
- 5 yrs + of experience in a GMP manufacturing environment; BS/BA Degree Preferred
- Proven track record of success in a fast-paced production environment at a biotech/pharmaceutical company preferably in GMP or GLP
- Ability to collaborate fluidly with peers, supervisors and cross functional support groups required
- Exceptional written, oral communication, and organizational skills required
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.