Chemist
A pharmaceutical Company is seeking a Chemist with 3-10
years of experience in generic pharma industry. Thorough
understanding of HPLC and other chromatographic techniques
is essential. Will be involved in day to day to generation
of analytical data in support of activities inclusive
of procedures utilizing HPLC analysis, dissolutions,
and method validations. Job requires multitasking of
data generation and reporting, trouble shooting and
analyzing results. Interacting with internal and external
customers in oral and written communication modes. It
is essential the candidate is committed to work in a
fast paced environment with quality and customer satisfaction
as priority.
Job Responsibilities:
1. Conducting analysis using HPLC/GC/UV/KFT/IR instrumentations
for the purposes of Assay, Dissolution and other test
procedures. Responsibilities will include, but not limited
to, from preparation to data analysis and interpretation
and troubleshooting stages.
2. Documenting and maintaining the analytical records/results
in the notebook as per cGMP.
3. Reviewing peer chemists' notebooks as per cGMP.
4. Performing validations and method transfers when
required.
5. Writing protocols and reports on analysis and validations.
6. Interfacing with Clients, Development Laboratory
and Contract Manufacturing.
7. Writing and reviewing SOPs related to laboratory
or analytical testing.
8. Other responsibilities as assigned by the Supervisor
or Department Head.
Requirements:
B.S. in Chemistry a must. 3-10 years experience in pharmaceutical
analytical laboratory, instrumental analysis and analytical
method development/validation. Hands-on experience on
HPLC Empower/Millennium/Turbochrom Software and Dissolution
required. Must be organized, detail oriented, self-motivated,
cooperative and have excellent analytical and people
skills. Able to work independently and possess computer
skills including Microsoft Excel, Word and Access (or
equivalent).
Apply
Now!
Go
to the top
Manager,
Quality Control (Raw Materials)
An expanding pharmaceutical company in New Jersey seeks
a Manager, Quality Control (Raw Matrerials) for overseeing
the day to day operations of the QC Raw Materials group.
Supervision and enforcing Laboratory cGMP's, conducting
investigations, methods transfer, qualification of second
source materials and training of new employees.
Duties and Responsibilities
- Supervise day to day operations of QC Laboratory to
ensure that cGMP's, and all other applicable compendial
requirements are met.
- Ensure that the testing is done as per the approved
- Monograph procedures, investigate and take corrective
actions, document investigation findings and coordinate
the approval process of investigations.
- Review and update SOP's and procedures for the QC
Group as needed. Review and comment on the articles
effecting QC in the USP Supplements and Pharmacopeial
Forums. Conduct periodic audits of the analysts' notebooks
to ensure compliance of cGMP's.
- Interact with Planning, Purchasing, Production and
QA
- Groups for timely release of the products.
- Coordinate workload sharing with other groups in QC
and develop action plans to improve the working environment
and for maximization of laboratory efficiency.
- Coordinate Analytical Methods Transfer projects and
reduce testing activities.
- Identify and implement procedures to reduce Cost of
Goods.
- Evaluate potential candidates for QC and performance
evaluation of direct reports.
- Provide training in all procedures, instrumentation
and Techniques, including but not limited to HPLC, UV-Vis,
IR, and Raw Material, Finished Product and Stability
testing.
- Prepare monthly report of the issues, work done, any
Employee related issues and conduct bi-weekly audits
of the analyst's notebooks.
- Develop systems and processes for proactive management
of laboratory logistics and instrumentation.
- Oversee ordering of lab supplies in observance of
Departmental Budget constraints.
Requirements:
- BS in chemistry or related discipline with at least
5-7 years supervisory experience in pharmaceutical testing
or MS in Chemistry or related discipline with 3-5 years
supervisory experience in pharmaceutical testing.
- A minimum of 3 years supervisory experience in pharmaceutical
industry.
- Excellent written and oral communications skills with
a strong emphasis on organizational capabilities.
- Demonstrated management and leadership experience
with strong interpersonal and influencing skills.
- Demonstrated flexibility in carrying out varied assignments
in a high quality work environment.
Apply
Now!
Go
to the top
Lab
Operations Manager
Lab Operations Manager
Quality Technical Services & Lab Operations
New York
Description of Duties and Responsibilities:
The Lab Operations Manager will be responsible for managing
the day to day activities of the bench chemists and
related laboratory activities. This includes general
enforcement of laboratory GMPs, technical documentation
reviews, assisting chemists experiencing instrumentation
problems, taking the lead role in the performance and
documentation of laboratory investigations, training
new chemists and training of staff on new and/or revised
procedures
o Transfer of analytical methods for stability testing
of drug products.
o Conducting stability testing and analysis of stability
results
o Writing/reviewing/approving of analytical methods,
stability protocols and reports.
o Writing/reviewing/approving of stability reports for
regulatory submission.
Requirements:
Ph.D (preferred) in chemistry or a directly related
field with 5-7 years of experience in a pharmaceutical
laboratory and a thorough knowledge of laboratory GMPs.
MS degree with 9 years in stability testing and validation/transfer
of analytical methods in a pharmaceutical stability
testing laboratory.
Previous supervisory experience would be a distinct
advantage.
Strong background in HPLC and GC (packed and capillary
column techniques)
Strong background in the statistical analysis of analytical
data
Knowledge of spectroscopic methods of analysis
Knowledgeable in laboratory cGMP
Effective verbal and written technical communication
skills
Ability to work in a fast paced environment
Apply
Now!
Go
to the top
Senior Manager/Associate Director QA/QC
Senior Manager/Associate Director QA/QC
Location: California (Company Paid Relocation program)
Develop appropriate QA/QC Systems employing best practices
from a corporate standpoint.
Develop the QC laboratory function in terms of personnel
and equipment to provide timely and GMP compliant release
of raw materials, process intermediates and finished
product.
Provide direction regarding test method development
and validation.
Oversee and mentor QA personnel as related to the development
of corporate-wide procedures, documentation, change
control and product release.
Develop and oversee all stability related testing.
Coordinate all required GMP training activities.
Other duties as required (i.e. assist in GLP oversight).
Position reports directly to the VP/Quality.
2. Minimum qualifications including prior experience
and knowledge required in order to perform this job:
At least 10 years of pharmaceutical QA/QC experience,
5 of which are in a supervisory/management capacity.
3. Minimum training/education required in order to perform
job and develop functionally in this position:
Position requires a minimum of a Bachelors Degree in
chemistry/biology or a related area
4. Additional Desirable Qualifications necessary to
successfully perform this position:
Strong knowledge of QA/QC requirements at the pre-IND
and IND stages.
Ability to work with little or no supervision while
working within the corporate Quality System
Apply
Now!
Go
to the top
|
