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ANI Pharmaceuticals provides equal employment opportunities to all persons without regard to race, sex, national origin, religion, age, disability or veteran status. We encourage diversity within each department and the Company as a whole. Equal Employment Opportunity guidelines are used every time we interact with our applicants and employees and include, but are not limited to recruiting, hiring, promotion, transfer, training, discipline and termination.
Laboratory Equipment Specialist
This position is responsible for assisting with administration of the Chromatography Data System (CDS) and other 21 CFR Part 11 compliant systems. Additional responsibilities include assisting with the purchase and qualification of new analytical equipment and software, troubleshooting and repairing equipment issues, and maintenance of equipment in the QC Laboratory.
Position Responsibilities: Provide user support for the Quality Control Laboratory regarding the CDS including adding new instruments, developing of methods and reports and assisting with daily system maintenance. Qualification of new and existing analytical equipment and instrumentation including any computer and the software/firmware required to control such equipment or instrumentation. Troubleshoot/repair instrumentation including coordinating with external vendors and maintaining equipment per governing procedures. Provide training on how to use the CDS and other instrumentation. Create, update and maintain validated Excel workbooks used within the laboratory. Performs other duties as assigned or requested.
Position Requirements: Minimum Education
- Bachelors Degree in Chemistry, Engineering or another related field
- 1 year in a Pharmaceutical Quality Control analytical laboratory.
- 2 - 5 years in an analytical chemistry lab in a Pharmaceutical or similarly regulated environment
Minimum Field of Expertise
- Ability to coordinate and manage multiple projects in a fast-paced environment.
- Ability to solve complex issues and assignments independently with minimum supervision.
- Ability to train and influence others to use new technology in the laboratory.
- Attention to detail
- Excellent Organizational and follow through skills
- Excellent technical writing skills.
- Excellent written and verbal communication skills.
- Must be able to work well within a team environment
- Knowledge of GMPs and 21 CFR Part 11
- Knowledge of USP 1058 Analytical Instrument Qualification
- Knowledge of Waters Empower Software
- Knowledge of Windows based networking and operating systems
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| TopOperator I - Production (1st, 2nd and 3rd Shift)
This position is responsible for operating pharmaceutical packaging machines/equipment.
1st Shift - Monday - Friday 7:30 am to 3:30 pm
Packaging Operator - $15.00 per hour
Manufacturing Operator - 15.75 per hour
2nd Shift - Monday - Friday 3:15 pm to 11:15 pm
Packaging Operator - $15.00 per hour plus $1.25 per hour Shift Differential
3rd Shift - Sunday - Thursday 11:15 pm to 7:15 am
Packaging Operator - $15.00 per hour plus $2.50 per hour Shift Differential
Position Responsibilities: Assists in material handling, equipment set-up and breakdowns, documents process according to Master Production Records, and works with trained operators at assigned work centers to learn all aspects of the position, including batch record documentation, equipment set-up, operation and clean up.
Position Requirements: This position requires a High School Diploma or equivalent, 1-2 years experience preferred. Must be 18 years or older. Must have the ability to perform repetitive work and meet ANI Pharmaceuticals standards. Must be able to read, comprehend and follow written and verbal instruction with accuracy. Must have the ability to read, comprehend and follow written and verbal procedures. Must have excellent accuracy/attention to detail. Must have good basic communication and interpersonal skills. Must be able to lift a minimum of 25 pounds. Understanding of GMP requirements is preferred and a plus.
Other preferred qualifications include the ability to wear personal protective clothing/equipment and hearing protection where provided and must be able to work varying shifts.
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| TopQC Chemist/Sr. QC Chemist
The QC Chemist position is responsible for independently performing testing in a pharmaceutical Quality Control laboratory. All work will be conducted in accordance with standard operating procedures and test methods. This includes performing testing on raw material, in-process and finished product samples. Execute compendia method validations, method transfers and validation support of new product development. Set up and confirm suitable operation of equipment and instrumentation. Collect data and generate/report results in accordance with governing test methods and SOPs.
Position Responsibilities: Perform review of data collected under approved test methods and investigational plans and protocols, in accordance with governing SOPs. Provide accurate assessment of data integrity, and document findings.
Perform calibrations, preventive maintenance and repairs as needed on instrumentation. Qualify new equipment as assigned. Perform cGMP tasks such as laboratory housekeeping, auditing documentation and ordering supplies. Perform other duties as assigned or requested.
Position Requirements: - Bachelors degree in chemistry, biochemistry, microbiology or closely related field/major.
-QC Chemist - 1-3 years experience, with 2-5 years experience preferred, in a chemistry lab in the pharmaceutical, food, or other closely related industry.
-Sr. QC Chemist - 2-5 years experience, with 5+ years experience preferred, in a chemistry lab in the pharmaceutical, food, or other closely related industry.
- Ability to read and follow written procedures
- Attention to detail.
- Ability to work with minimal supervision
- Problem solving skills
- Organization, communication and interpersonal skills.
- Understanding of good laboratory practices and analytical techniques.
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| TopSr. Scientist I - MPS
The Senior Scientist I – Marketed Product Support (MPS) independently leads technical projects as assigned by the head of Product Development. He/she is responsible for providing technical oversight and recommendations to support currently marketed products including but not limited to alternate materials, process improvements, investigations, and technology/site transfers.
Primarily responsible for managing technology transfer and other MPS projects while following good Manufacturing Practices (cGMPs):
• Authors and executes documents such as protocols, reports, batch records, and technical assessments.
• Plans/executes experiments and analyzes data. Records data in laboratory notebooks.
• Able to use statistics to plan experiments and analyze data (e.g. Design of Experiments, Statistical Process Control, Process Capability)
• Evaluates and/or proposes equipment purchases
• Tests/evaluates characteristics of new raw materials and/or packaging components
• Provides Manufacturing, Validation, Packaging, and Regulatory Affairs, with technical input.
• Assists in training operations on new products/processes.
• Provides technical input on investigations and/or CAPAs associated with manufacturing and packaging of marketed products.
• Proactively identifies manufacturing/packaging process improvements.
• Professionally interacts with third parties
Assists with improving department infrastructure and procedures. Helps to develop best practices related to MPS and/or technical writing.
Maintains department Standard Operating Procedures (SOPs). Initiates, creates, and revises SOP’s as appropriate.
Performs other duties as assigned or requested.
Education - Bachelors, Masters, or Ph.D. in Chemical Engineering, Chemistry, Biology, or a related science.
Experience - Minimum of 4 years with a Ph.D., minimum of 7 years with a Masters, minimum of 9 years with a Bachelors.
Must have the ability to coordinate multiple projects in a fast-paced environment. Must have demonstrated ability to perform in a team environment. Must have excellent communication skillls, organizational and follow-through skills and interpersonal skills. Other requirements include troubleshooting ability, understanding of GMPs, ability to plan, organize, implement, and product transfer projects, plans and objectives. Demonstrated leadership skills. Strong technical writing ability, Familiarity with FDA guidance related to Marketed Product Support (MPS) (e.g. SUPAC, Stability) Previous pharmaceuticals industry experience.Submit Resume
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