Job description

Analytical Technology Transfer Scientist

Our client is a Global Pharmaceutical CDMO and they have an immediate opportunity for an Analytical Scientist with Tech Transfer experience to join their team. Company offers a competitive compensation & benefits package and stable employment.

ESSENTIAL JOB RESPONSIBILITIES:

Required:

• Perform analytical method technology transfer including method verification and method validation.
• Read and interpret analytical methodology and USP monographs.
• Perform analytical testing of pharmaceutical drug products and/or raw materials following analytical methodology while adhering to internal and external customer requirements and schedules.
• Maintain accurate, detailed records of work performed using LIMS and other laboratory software.
• Operate UPLC/HPLC/GC as well as other analytical instruments and perform troubleshooting and calibration as needed.
• Review laboratory data and laboratory records for accuracy and compliance to procedures.
• Write laboratory related documents including protocols, reports, and/or methods.
• Participate as a lab lead on inter-departmental teams for new product introduction/improvement activities. Execute technology transfer and/or validation protocols to support these teams.
• Assist in the development of laboratory expertise in analytical technologies to increase the capability to support internal and external customers for future requirements.

JOB QUALIFICATIONS:

Required:

• Experience in analytical method development and validation.
• Perform routine analytical chemistry drug product, drug substance, and excipient testing according to approved methodology in a regulated pharmaceutical analytical laboratory.
• Experience in UPLC/HPLC/GC and other spectroscopic instruments.
• Proficient in analytical method verification/validation and technology transfer activities including technical writing and cleaning validation.
• Ability to perform calibrations and troubleshoot analytical instrumentation as needed.
• Knowledgeable in USP, ICH, cGMP, and cGLP requirements.
• Organized and detail oriented, self-driven, and capable independently solving problems.
• Capable of handling multiple projects at one time, and changing priorities based on business needs.
• Excellent interpersonal, oral, and written communication skills.
• Proficient in MS Office applications and other laboratory software applications.
• Able to work effectively independently and as part of a team.
• Able to work overtime, including weekends, when required

Preferred:

• Experience in XRD, ICP-MS, FTIR, TOC, and/or Malvern 3000 Mastersizer instrumentation.
• Experience in analytical method development and validation.
• Proficient in analytical technical writing related to protocols, reports, and methodology.

EDUCATION REQUIREMENTS:

Required:

• Bachelor’s degree in chemistry or related science
• Minimum of three years of related laboratory experience

Job Type: Full-time

Pay: $70,000.00 - $80,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible schedule
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Referral program
• Retirement plan
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Hatfield, PA: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Required)

Experience:

• Laboratory experience: 3 years (Required)
• Analytical chemistry: 3 years (Required)
• CGMP: 3 years (Required)
• Gas chromatography: 3 years (Required)
• High-performance liquid chromatography: 3 years (Required)

Work Location: In person

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