Cell Therapy Manufacturing Technician II job in Philadelphia, USA

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: Biological Sciences, Medicinal Chemistry, Pharmacology

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is seeking a Cell Therapy Manufacturing Technician II for a top biopharmaceutical company located in Philadelphia, PA.

Job Responsibility:

Develop a comprehensive understanding of and be able to proficiently execute our current cell therapy manufacturing process.
Complete training sessions and ensure training documentation is maintained.
Understands and complies with quality standards and requirements as documented.
Provides operational support functions including materials stocking, kit preparation, reagent preparation, cleaning activities, and equipment maintenance.
Supports technical transfer and additional research level testing activities.
Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements.
Support documentation needs, which may including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to accurately reflect current procedures.
Attends the daily lab meeting and escalates issues/concerns at that forum to Area Management for further investigation.
Ability to work in a team environment and independently as required. Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
Other duties as assigned.

Skills and Requirements:

Preferred not required B.S. degree in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience.
Experience in biopharmaceutical based GMP manufacturing operations, including experience in cell culture and associated downstream processing.
Demonstrated technical knowledge of aseptic processing in cleanroom environments is a must.
Ability to mentor and provide best practices to other members of the team.
Ability to build relationships quickly and credibly.
Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
Proactive, results oriented, self-starter with experience in a complex manufacturing environment.
Ability to work successfully in a fast-paced team-oriented environment.
Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
Must adhere to our core values, policies, procedures and business ethics.
Aseptic Manufacturing Technicians II are required to work their assigned schedule. This position is currently for regular work week hours (1st shift M-F); however, due to the nature of cell therapy manufacturing schedules, must be willing to work alternative shifts, weekends, evenings, and holidays, as needed. It is also expected that regular work weeks may change once commercial manufacturing commences and may involve shift changes (i.e. Tuesday to Saturday). May be required to work overtime.
Need to be able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook).
May require up to 5% travel, based on business need.
Must be able to work in environment with variable noise levels
Must be able to work in Lab setting with Biohazards /various Chemicals
Clarity of vision at near and mid-range, depth perception, ability to identify and distinguish colors.
Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
Works in production environment with exposure to latex and bleach. Potential exposure to noise and equipment hazards and strong odors.
Ability to stand/sit/walk for long periods of time
Ability to crouch, bend, twist, reach, and perform activities with repetitive motions
Ability to lift 20 lbs

If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at (+1) 267-428-7770 or m.raletz@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-MR2