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Associate, GMP Manufacturing

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POST DATE 9/14/2016
END DATE 11/23/2016

Moderna Therapeutics Cambridge, MA

Company
Moderna Therapeutics
Job Classification
Full Time
Company Ref #
R216
AJE Ref #
576169611
Location
Cambridge, MA
Experience
Entry Level (0 - 2 years)
Job Type
Regular
Education
Bachelors Degree

JOB DESCRIPTION

APPLY
Associate, GMP Manufacturing

POSITION SUMMARY

Moderna is seeking a GMP Manufacturing Associate for a position based at their Cambridge, MA site. The individual in this role will be part of a cohesive team responsible for producing high quality mRNA-based medicines for evaluation in human clinical trials. He/she will apply existing and new knowledge of bioprocess unit operations and cGMPs to enable technical success with stringent adherence to a Quality System that respects global regulatory expectations. 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 bioprocessing 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.

RESPONSIBILITIES

* Be a consistent contributor on a production shift, under the guidance of a shift leader.

* Demonstrate general knowledge of standard laboratory practices and equipment.

* Demonstrate an understanding of GMPs & how it applies to specific responsibilities.

* 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, such as pilot-scale chromatography systems.

* Assist in the investigation of procedural deviations.

* Practice safe work habits and adhere to Moderna s 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.

MINIMUM QUALIFICATIONS

* 1-3 years of professional/industrial cGMP experience in a biotechnology, medical device or pharmaceutical company

PREFERRED QUALIFICATIONS

* Bachelor or Master s degree in Biology, Biochemistry, Molecular Biology, Chemistry or Chemical Engineering

* 1-3 years of professional/industrial cGMP experience in a biotechnology, medical device or pharmaceutical company

* Subject Matter Expert on the set up/use/process of TFF Systems, GE AKTA systems, single use process materials/consumables

COMPETENCIES

* Technical / Professional Knowledge

* Technical Transfer

* Aligning Performance for Success

* Decision Making

* Detail Oriented

* Energy

* Facilitating Change

* Planning and Organizing

* Safety Awareness

* Stress Tolerance