Biopharm Manufacturing Associate

Synectics Inc.; King of Prussia (Montgomery County); On-site; USD 24,000 - 27,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a Biopharm Manufacturing Associate in King of Prussia. The successful candidate will be responsible for completing manufacturing tasks, documenting processes accurately, and ensuring safety compliance. This entry-level position offers competitive pay and a range of benefits including healthcare, dental, vision, and a technical certification bonus.

Benefits

Healthcare Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Technical Certification Bonus

Qualifications

• 1+ years experience in cGMP.
• Familiarity with upstream equipment and process.
• Fluent in English with clear communication skills.

Responsibilities

• Complete daily manufacturing tasks following SOPs.
• Document all manufacturing activities clearly.
• Maintain compliance with all safety regulations.

Skills

Attention to detail

Communication

Problem solving

Education

Bachelor of Science degree in Chemical Engineering, Biology, Chemistry, or other engineering or scientific field

Job description

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• Completing daily manufacturing tasks per standard operating procedures and batch document instructions.
• Documenting all manufacturing activities clearly and accurately.
• Ensures all production activities are completed in a safe and compliant manor.
• Maintain and prepare high quality documentation.
• Dispense large and small amounts of raw materials Perform CIP and SIP of product tanks.
• Work with hazardous materials under the appropriate safety procedures
• Performs other functions as necessary or as assigned.
• Preparation, cleaning, sterilization, batching, pasteurization or filtration and delivery of media and solutions for cell culture and purification operations.
• Perform the set-up, operation, cleaning and break-down of process equipment.
• Perform sampling procedures on various analytical instruments to analyze cell culture, solution and/or product concentration characteristics.
• Operate Filter integrity devices to confirm the integrity of filters pre and post use.
• Perform process operations, equipment and instrument monitoring and trending to enable proactive identification of issues to escalate and correct with applicable departments.
• Set-up of fixed and mobile process equipment and parts with CIP skids to carry out validated cleaning and sterilization processes.
• Follow appropriate standard operating procedures (SOPs), protocols and batch records/logbooks to safely perform process operations and document compliantly with good documentation and data integrity practices.
• Follow all related safety policies and procedures and Put safety first by playing an active role in identifying and correcting unsafe behaviors and conditions.
• Ability to choose a type of communication that is most effective in each situation.
• 1st shift standard day shift (i.e. Mon-Fri; 40 hrs/wk; 8 hrs/day; 7:30 AM - 4:00 PM)
  
  

Description

• Completing daily manufacturing tasks per standard operating procedures and batch document instructions.
• Documenting all manufacturing activities clearly and accurately.
• Ensures all production activities are completed in a safe and compliant manor.
• Maintain and prepare high quality documentation.
• Dispense large and small amounts of raw materials Perform CIP and SIP of product tanks.
• Work with hazardous materials under the appropriate safety procedures
• Performs other functions as necessary or as assigned.
• Preparation, cleaning, sterilization, batching, pasteurization or filtration and delivery of media and solutions for cell culture and purification operations.
• Perform the set-up, operation, cleaning and break-down of process equipment.
• Perform sampling procedures on various analytical instruments to analyze cell culture, solution and/or product concentration characteristics.
• Operate Filter integrity devices to confirm the integrity of filters pre and post use.
• Perform process operations, equipment and instrument monitoring and trending to enable proactive identification of issues to escalate and correct with applicable departments.
• Set-up of fixed and mobile process equipment and parts with CIP skids to carry out validated cleaning and sterilization processes.
• Follow appropriate standard operating procedures (SOPs), protocols and batch records/logbooks to safely perform process operations and document compliantly with good documentation and data integrity practices.
• Follow all related safety policies and procedures and Put safety first by playing an active role in identifying and correcting unsafe behaviors and conditions.
• Ability to choose a type of communication that is most effective in each situation.
• 1st shift standard day shift (i.e. Mon-Fri; 40 hrs/wk; 8 hrs/day; 7:30 AM - 4:00 PM)
  
  

Requirements

• Bachelor of Science degree in Chemical Engineering, Biology, Chemistry, or other engineering or scientific field.
• Experience and knowledge of cGMP guidelines and standards. (1+ years)
• Knowledgeable of upstream equipment (aka unit operations) and process overview (media prep, small scale, large scale), Analytical equipment (VI-Cell, NOVA, Centrifuge, tubing welder), PLC / DCS / HMI
• Proficiency in executing standard procedures required in addition to some non-routine work.
• Familiarity with Good Manufacturing Practices (GMP) regulations.
• Ability to work in highly matrixed organization.
• Ability to multi-task within a multi-functional team environment.
• Able to troubleshoot.
• Capable of following written instructions and have clear written communication skills as well as computer literacy.
• Familiar with basic scientific principles and have experience in routine bench work and/or instrumental analysis.
• Ability to author, revise and/or support SOP's, change controls, deviations.
• Pharma knowledge and background preferred.
• Fluent in English, strong communication skills required.
  
  

Benefits

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Contract

Job function

• Job function

  Science

• Industries

  Staffing and Recruiting

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