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Process Associate II - (Downstream/Support Operations)

LanceSoft INC
Exton, Pennsylvania, 19341, United States
April 10, 2019



Job Summary

Under supervision and guidance, the contractor for Downstream/Support Operations will participate in the execution activities for scale-up and system operations supporting the manufacture of preclinical, clinical, and commercial biologics drug substances. The individual will provide manufacturing support for purification, formulation, operation of chromatography columns and controllers, TFF skids, viral filtration technologies, and CIP/SIP operations. The individual will also provide manufacturing support in support operations such as preparation of media/buffer solutions utilizing disposable mixing technology, raw material sampling and submission, preparation of process equipment using a washer and autoclave. The individual will also be responsible for GMP documentation, troubleshooting of process equipment, preparation and close-out of documentation and ensuring compliance to relevant regulations. In addition, the individual will be responsible for hands-on execution of the routine operation, maintenance, and periodically requalification of pilot plant production equipment and production suites in a cGMP biopharmaceutical pilot plant.

Essential Functions

Responsibilities Percent of Time

1. Work in a hands-on capacity in the operation of production support and downstream equipment for the manufacture of preclinical, phase I and phase II clinical trial materials. Assist in the coordination of equipment maintenance, calibration, and validation with appropriate internal departments. Provide cross-functional support for other departments within the pilot plant at the discretion of management. 50

2. Ability to follow oral and written instructions, maintain neat, accurate, and current training and GMP records 10

3. Performs all work duties via automated systems or manual operations in compliance with safe operating procedures, company and government regulations, and good manufacturing practices 10

4. Assist in the preparation of bill of materials, batch records, SOPs, and close-out reports for each campaign. 10

5. Ensure adherence of operations to cGMP, ICH, EMEA and JP Guidelines as well as industry safety standards and OSHA guidelines. 10

6. Assist in troubleshooting product and equipment issues and deviations. 5

7. Interact cross-functionally with Downstream Operations, Support Operations, Facilities, R&D, Quality Assurance, Quality Control, Validation, and other internal and external functions to support successful product development. 5


Reporting Relationships

Reports to Operations Manager

Scope Measures

The individual will play a key role in the execution activities for scale-up and system operations supporting the manufacture of preclinical, clinical, and commercial biologics drug substances to support Client’s clinical development pipeline.

Specifically, this person will contribute to the success of the operation by providing technical support for purification and formulation equipment and processes for the manufacture of materials for global clinical supplies. The individual will also assist in the preparation of clean and sterile supplies, as well as medium and buffer solutions used in the manufacture of Phase I/II clinical trial material. The individual will also participate in monitoring and maintaining and/or enhancing the production area processes and technology to remain compliant to regulations and to ensure successful transfer of new products from development to GMP Operations.

Knowledge/Skills/Abilities Required

• Minimum level of education and years of relevant work experience,

• Special knowledge or skills needed and/or licenses or certificates required,

• Physical requirements

Education: BS in Biological Sciences or Engineering or equivalent job experience/degree is strongly preferred.


• Minimum of 3-5 yrs (BS) in a multi-discipline cGMP environment, operating equipment in downstream and support production areas.

• Proficient in the operation of all area-specific production equipment such as chromatography columns and controllers, TFF skids, viral filtration technologies, autoclaves, glassware washers, CIP/SIP operations, Large scale bioprocessing utilizing disposable mixing technology for media and buffer manufacturing.

• Must be willing to work any shift in supporting 24/7 bulk operations that may include weekend, holidays and overtime, as required.

• Must be able to sit and/or stand for extended periods of time and be able to lift 25lbs.

• Self-starter with a strong focus on detail, safety, quality and results.

• Ability to multi-task and adjust to varying priorities to meet timelines.

• Experiences in technology transfer, scale-up, equipment validation and facility startup.

• Ability to identify, investigate, and trouble-shoot basic process and equipment problems.

• Working knowledge of cGMP, EMEA, and JP regulations.

• Good written and communication skills.

• Good problem solving and interpersonal skills with the ability to work in a team environment required.