JOB QUALIFICATIONS (Training, skills, experience):
Required:
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.
- 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.
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EDUCATION REQUIREMENTS:
Required:
- Bachelor's degree in chemistry or related science
- Minimum of three years of related laboratory experience
Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited's investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.
In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.
Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.
Equal employment opportunity
Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.
We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.