Associate Scientist - 1st and 2nd Shift - Downstream Cell Processing Operations - GMP

PPD - Hopewell, NJ (30+ days ago)3.5


Associate Scientist - 1st and 2nd Shift - Downstream Cell Processing Operations - GMP - 145602

Description
EXPECT MORE FROM YOUR CAREER
EXPECT PPD


PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD Laboratories FSP. PPD Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD.

As an Associate Scientist, you will use state-of-the-art technologies to execute downstream operations at a large pharmaceutical client site. You will perform purification and packing of protein based pharmaceuticals, prepare stock solutions, filtration of stock solutions, and cleaning and assembling of equipment.

Additional responsibilities for the role on site at a major pharma/biotech company:
  • Purification and packaging of protein based pharmaceuticals.
  • Preparation of stock solutions.
  • Filtration of stock solution.
  • Cleaning, set-up of Chromatography skids, Filtration Skids and Columns.
  • Set-up and operation of disposable bioprocess equipment.
  • Pack and Unpack Chromatography Columns.
  • Stock raw materials and consumables.
  • Remove waste from facility.
  • Works on routine manufacturing assignments per written procedures, where ability to recognize deviation from accepted practice is required.
  • Adheres to current Good Manufacturing Practices (cGMP) and standard operating procedures.
  • Weighs and checks raw materials, assembles and cleans process equipment, and monitors processes.
  • Completes work instructions and maintains clean room environment to comply with regulatory requirements.
  • Trains for proficiency in the operation of primary production equipment such as buffer preparation vessels, chromatography skids, columns and disposable equipment.
  • Authors and approves master batch records (MBRs) by transferring technical information from scientific and development documents.
  • Collaborates with equipment and instrument vendors to become subject matter expert. Authors, revises and approves SOP’s for such equipment.
  • Leads or participates on Operational Excellence cross-functional project teams, including but not limited to Development, Quality, Analytics, Logistics, Facilities and Document Center. Utilizes Continuous Improvement and Project Management tools for completion of projects.
  • Investigates deviations for root cause and determines appropriate corrective actions (CA) and preventative actions (PA).
  • Implements CAPA within agreed upon timelines.
  • Designs and implements single use technology process consumables for new molecule facility fit and continuous improvement.
  • Conducts Safety and GMP self-auditing walkthroughs, documenting observations for assignment and closure dates.
  • Logs and submits samples in LIS. Tracks results and complies data.
  • Reviews and signs-off on completed batch records.
  • Assists mechanics and instrument techs with product change-over of equipment and manufacturing areas.
Grow your career within the scientific ladder, pursue project management, or develop into a leader. These are just a few career pathways available once you choose to Be with PPD.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk, our award-winning training programs speak for themselves.

Join PPD in our relentless pursuit of excellence - apply now!

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Qualifications
Education and Experience:
  • Bachelor's degree in a scientific related or engineering field
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 1+ year) or equivalent combination of education, training, & experience.).

  • Experience in aseptic technique and chromatography purification preferred

Knowledge, Skills and Abilities:
  • Knowledge of applicable regulatory authority, compendia and ICH guidelines
  • Ability to understand and independently apply GMPs and /or GLPs to everyday work with regard to documentation and instrument use
  • Ability to provide prior evidence of successful participation on work teams where combined contribution, collaboration, and results were expected
  • Ability to utilize Microsoft Excel and Word to perform tasks
  • Ability to independently optimize analytical methods
  • Good written and oral communication skills
  • Time management and project management skills
  • Problem solving and troubleshooting abilities
  • Ability to work in a collaborative work environment with a team and demonstrate good interpersonal skills
Working Conditions
  • Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment.
  • Occasional drives to site locations, occasional domestic travel.
  • Exposure to biological fluids with potential exposure to infectious organisms.
  • Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste.
  • Personal protective equipment required such as protective eyewear, garments and gloves.
  • Exposure to fluctuating and/or extreme temperatures on rare occasions.
Physical Requirements
  • Ability to work in an upright and /or stationary position for 6-8 hours per day.
  • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment.
  • Occasional mobility needed.
  • Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
  • Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
  • Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
  • Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
  • Frequently interacts with others to obtain or relate information to diverse groups.
  • Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.
  • Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
  • Regular and consistent attendance.
PPD is an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group.

key words: aseptic technique, GMP, GDP, single use equipment, cleanroom, clean room, purification, chromatography, manufacturing

Organization - Lab Operations
Primary Location - North America-United States-New Jersey-FSP Hopewell NJ