Generic Pharmaceutical Manufacturing - Formulations and Technical Services
Company: Chartwell Pharmaceuticals
Posted on: November 25, 2022
Chartwell Pharmaceuticals, LLC is a privately-held, US-based
generic pharmaceutical manufacturer with manufacturing sites in
Congers (Rockland County) and Carmel (Putnam County), New York, and
R&D Operations in Israel. With nearly 500 ANDA listings in the
FDA Orange Book, Chartwell is rapidly growing and transforming our
business as a full-scale Generic Pharmaceutical Manufacturer and
Distributor serving the Retail, State and Federal Government
Markets under the "Chartwell Rx" labels. This is an excellent
opportunity to get in on the ground-floor with a fast-growing and
dynamic generic pharmaceutical company!
Position HighlightsProvide scientific, technical and hands-on
support of Formulations and Technical Transfers of previously
approved dosage forms into the Chartwell Pharmaceuticals sites, or
to 3rd party sites. Must have a current understanding of
formulation development, QbD, and tech transfer process from
kick-off through validation. Possess strong technical skills in
pharmaceutical manufacturing, scale up and scale down processes and
packaging, relevant process equipment, formulations, API
characterization, pre formulation and excipients performance.
Should have knowledge of analytical methods. High sensitivity to
QA, RA, QC requirements for regulatory filings. Identify
opportunities to improve the process or materials to achieve best
cost and efficiency.
Specific Responsibilities and Assignments
- Work independently to design, conduct benchtop formulation
- Evaluate and document key ANDA/NDA approval details.
- Responsible for execution of lab scale, scale up and validation
- Perform gap analysis and characterize the changes required for
- Record experiments in laboratory notebooks.
- Compile data, data presentations, prepare product development
reports and author technical reports for submission/validation
- Perform scale-up studies and prepare technical transfer report
for cGMP manufacturing.
- Ability to operate small scale up manufacturing equipment.
- Identify problems, troubleshoot and offer solutions to advance
- Work with operations team to ensure equipment and capacity
readiness for all required work.
- Provide clear and accurate verbal and written reporting of
- Provide product status, with relevant materials for decision
- Perform maintain Research and Development lab
- Should meet project timelines and performance standards as
- Carries out responsibilities in accordance with organizational
policies and procedures.
- Perform other duties as assigned.
- Be challenge driven, willing to take on extra responsibility to
achieve organizational goals. Essential Skills
- Bachelor or Master's degree in a related scientific discipline
- Minimum 2 years of Pharmaceutical formulation and process
development, technology transfer and scale up experience supporting
technical and operational activities in liquid dosage forms.
- Experience and working in cGMP environment and knowledge in
- Superior problem solving, organizational and analytical skills,
highest attention to detail, and ability to proactively seek
multiple internal and external data sources and insights and
synthesize into meaningful observations and action plans.
- Superior communication skills (verbal, written and
- Highly ethical and transparent, with professional sensitivity
and care for confidentiality.
- Must have proficient computer skills. PLEASE NOTE:
- This position is based in Congers, NY and we only seek
candidates from the New York Metropolitan area.
- Candidates must meet all of the criteria in the qualification
- Sponsorship is not available for this position.
- Agency referrals are not accepted.
Keywords: Chartwell Pharmaceuticals, Yonkers , Generic Pharmaceutical Manufacturing - Formulations and Technical Services, IT / Software / Systems , Congers, New York
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