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Sr. Associate, GMP Manufacturing, 2nd Shift

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POST DATE 9/15/2016
END DATE 11/23/2016

Moderna Therapeutics Cambridge, MA

Company
Moderna Therapeutics
Job Classification
Full Time
Company Ref #
R217
AJE Ref #
576180136
Location
Cambridge, MA
Experience
Mid-Career (2 - 15 years)
Job Type
Regular
Education
Bachelors Degree

JOB DESCRIPTION

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Sr. Associate, GMP Manufacturing, 2nd Shift

POSITION SUMMARY

Moderna is seeking a cGMP Pilot Plant Senior Manufacturing Associate for a second shift position based at their Cambridge, MA site. The individual in this role will be capable of working in a cohesive high-performing team responsible for producing high quality mRNA-based medicines for evaluation in human clinical trials. He/she will apply their knowledge of standard bioprocess unit operations and cGMPs to enable technical success within a Quality System that respects global regulatory expectations. The successful candidate will be a critical thinker that can assess and communicate technical and Quality deviations, and take a primary role in troubleshooting and corrective actions. They will have strong observational and documentation skills and will serve as cross-functional ambassadors of the Manufacturing group to Quality Control, Quality Assurance, Logistical and Technology Transfer counterparts.

Second shift hours are 3:00 11:00 pm.

RESPONSIBILITIES

* Be a leadership figure on an evening shift, with accountability for team productivity.

* Demonstrate general knowledge of standard laboratory practices and equipment.

* Demonstrate an understanding of GMPs and uphold the highest GMP standards for their team.

* Establish and follow written procedures for the clear and accurate documentation of equipment operation, process instructions and process data.

* Train others on specific process operations as well as GMP principles.

* Monitor process operations to ensure compliance with specifications.

* Support equipment validation activities and support the care of high-value capital equipment, such as pilot-scale chromatography systems.

* Take a leadership role in the investigation of procedural deviations and non-conformances, working closely with Quality Assurance counterparts to develop and execute robust CAPAs.

* Be capable of assuming overall Batch Leader responsibilities, including the aggregation of in-process control, process parameter and quality attribute data for both Drug Substance and Drug Product processes, and accountability for batch documentation closeout with Quality Assurance counterparts.

* Coordinate closely with Warehousing personnel to assure seamless supply of raw materials and consumables from inventory.

* Coordinate with Facilities personnel on equipment and facility maintenance issues.

* Practice safe work habits and adhere to Moderna s safety procedures and guidelines.

* 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

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

* 3-5 years of cGMP operational experience in a biotech or pharmaceutical early or late-phase manufacturing facility.

* Experience with major pilot-scale chromatography, TFF and single-use equipment platforms.

PREFERRED QUALIFICATIONS

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

* 5+ years of professional/industrial cGMP experience in a biotech, diagnostic, therapeutic or pharma company

* Experience with major pilot-scale chromatography, TFF and single-use equipment platforms.

COMPETENCIES

* Aligning Performance for Success

* Coaching

* Decision Making

* Detail Oriented

* Developing Others

* Energy

* Facilitating Change

* Planning and Organizing

* Safety Awareness

* Stress Tolerance

* Technical / Professional Knowledge

* Technical Transfer