Careers

Available Positions

If you are interested in employment opportunities at ANI Pharmaceuticals, e-mail your resume to hr@anipharmaceuticals.com or visit here to begin the application process. All resumes are carefully reviewed to determine whether candidates meet the needs of open positions. Resumes that do not meet our immediate hiring needs are kept on file for three months and regularly reviewed for potential matches. Due to the number of resumes received, we cannot reply to all submissions.

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.

Position Location
Analytical Development Analyst Baudette, MN
Analytical Development Chemist Baudette, MN
Distribution Worker I Baudette, MN
Microbiologist Baudette, MN
Operator I - Production (1st, 2nd and 3rd Shift) Baudette, MN
QC Chemist Oakville, ON
QC Chemist/Sr. QC Chemist Baudette, MN
Quality Assurance Associate Oakville, ON
Sr. Scientist I - MPS Baudette, MN
Supervisor, Quality Control Baudette, MN


Analytical Development Analyst
This position is charged with independently performing laboratory procedures as defined by governing Standard Operating Procedures. This is an entry level professional position for Pharmaceutical Analysts.

Position Responsibilities: Responsibilities include but are not limited to:

Perform testing on material and product samples. Prepare standards, solutions, and samples in accordance with approved procedures. Set up and confirm suitable operation of equipment and instrumentation. Collect data and generate and report results in accordance with governing test methods and SOPs. Work with Supervisors to report discrepancies.

Perform review of data collected under approved test methods in accordance with governing SOPs. Provide accurate assessments of data integrity and document findings. Work with Supervisor and peers to correct deficiencies.

Perform maintenance and calibration, repair and qualifications on equipment and reagent and media as needed.

Perform cGMP tasks such as monitoring expiry dates, auditing documentation and logbooks and ordering supplies.


Position Requirements: Minimum Education and Experience.
Bachelors degree in Chemistry, medical technology, microbiology or closely related field or major. Must have experience in an analytical laboratory, academic or otherwise.

Preferred Education
Bachelors and/or post graduate education in Chemistry, Pharmacy or closely related field.

Preferred Experience
Experience following laboratory procedures and systems in Pharma or similarly regulated environment.
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Analytical Development Chemist
This position is responsible for independently performing testing in a pharmaceutical analytical development laboratory. All work will be conducted in accordance with standard operating procedures and test methods. This is a professional position that requires 2-5 years previous experience working in a laboratory performing chormatographic analysis and dissolution testing.

Position Responsibilities: Responsibilities include but are not limited to:

Perform testing on raw material, in-process, and finished product samples. Execute compendial method verifications, method transfers and validation in support of new product development. Set-up and confirm suitable operation of equipment and instrumentation. Collect data and generate and report results in accordance with governing test methods and SOPs. Work with management in the vent of discrepancies.

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. Work with management and peers to correct deficiencies.

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.

Position Requirements: Minimum Education and Experience
Bachelors degree in chemistry, biochemistry, microbiology or closely related field or major.
1-3 years experience in a chemistry lab in the pharmaceutical, food or other closely related industry.

Preferred Education and Experience
Bachelors degree or advanced degree in chemistry. 2-5 years experience in an analytical chemistry lab or other closely related industry.
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Distribution Worker I
This entry level position is responsible for performing a combination of distribution functions.

Position Responsibilities: These responsibilities include order fulfilment, receiving, stocking of materials, replenishments, cycle counting, and returned goods within the inventory control area. Performs packing, labelling, checking and confirming in the Shipping area. Works with the parcel shipping and Bill of Lading systems. Operates an electric pallet jack, and forklift operation for loading/unloading trucks.

Position Requirements: A minimum of a High School Diploma or equivalent is required. 1-2 years warehousing/materials management or other related experience is preferred. Computer skills in Microsoft Windows Environment is also preferred. Must be able to lift up to 50 pounds. Must have the ability to perform tasks in an efficient manner that meets company standards of accuracy, quality, productivity and ensuring compliance with OSHA standards, SOPs and GMPs. Must have the ability to read, comprehend and apply written and verbal communications accurately and the ability work in a methodical and organized fashion with excellent attention to detail. Must have excellent interpersonal, communication, organizational, and follow through skills as well as the ability to work independently with minimal supervision and also the ability to work within a team environment.
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Microbiologist
This position is responsible for independently performing microbiological testing, as defined by governing standard operating procedures. This is an entry level professional position in the Quality Control Microbiology Laboratory.

Position Responsibilities: - Perform microbiological testing on raw materials and finished product samples. Prepare standards, stock cultures, microbiological media and samples in accordance with approved methods. Identify microorganisms.
- Set-up and confirm suitable operation of equipment and instrumentation. Collect data and generate/report results in accordance with governing test methods and SOPs.
- Perform review of data collected under approved methods. Provide accurate assessments of data integrity, and document findings.
- Perform calibration, preventative maintenance and repairs as needed on instrumentation.
- Perform cGMP tasks such as laboratory housekeeping, auditing documentation, and maintenance of microbiology laboratory supplies.


Position Requirements: - Bachelors degree in Microbiology, Biochemistry, or closely related field.
- Experience in a microbiology laboratory, academic or otherwise.
- Ability to coordinate multiple tasks in a fast-paced environment
- Ability to read and follow procedures
- Ability to work independently and under minimal supervision.
- Demonstrated understanding of good analytical technique.
- Organization, communication and interpersonal skills.
- Ability to handle fine glassware, sampling devices and perform data entry.

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Operator 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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QC Chemist
- Performs chemical and physical testing of finished products, raw materials and stability samples.
- Accurately document all tests/test materials/equipment used and all results obtained in a timely manner.
- Participate in Laboratory and Non-Conformance Investigations.
- Responsible for the safety and housekeeping of the Laboratory.
- Follows the responsibilities as outlined in the Ontario Health and Safety Act.
- Supports continuous improvement initiatives.
- Other duties as assigned by QC Supervisor / Manager.


Position Responsibilities: 1. Performs testing of raw materials, finished product and / or stability:
- Follows cGMP and cGLP guidelines, SOPs and methods
- Possess strict adherence to data integrity principlesConducts physical and chemical tests on raw materials, in-process, finished product and stability using an array of instruments (including HPLC/GC, UV-VIS and FT-IR spectrophotometers, titrators, dissolution apparatus and pH meters) under minimal supervision
- Provide timely, clear and high-quality data reports that document test results
- Assist in investigations of laboratory events and deviations
- Work on multiple projects in a fast-paced environment

2. Responsible for the Safety and Housekeeping of the Laboratory.
(A) Safety
- Follows MSDS and WHMIS to ensure that QC reagents, chemical labels and information conform to current WHMIS legislation
- Works in compliance with the safety provisions of ANI Pharmaceuticals Canada Inc and applicable government agencies by wearing/using protective equipment/devices specified by procedures/test methods or verbal instructions from Manager or Supervisor

(B) Housekeeping
- Maintains the allocated work area and equipment in good housekeeping conditions during working hours and at the end of the work day
- Ensures that chemicals/solutions are stored and disposed of according to applicable SOPs

3. General Health & Safety

Performs responsibilities of job function in a safe manner, by:
- Adhering to all ANI Pharmaceuticals Canada Inc written/verbal Health & Safety instructions
- Reporting safety hazards, including non-conformance with ANI Health & Safety Procedures, to management
- Reporting work-related injuries and/or illnesses to management immediately upon occurrence
- Participating in the maintenance of a safe working environment for self and fellow employees

4. Professional Development

- Maintains current knowledge of industry standards for Quality Control requirements
- Participates in training and development as required


Position Requirements: 1) Bachelor of Science degree in Chemistry/Biochemistry or a related College Diploma with a minimum of 2 years experience in a pharmaceutical laboratory.
2) In-depth understanding of chromatography principles, types and techniques.
3) Working knowledge of laboratory instrumentation including HPLC/GC, UV-VIS and FT-IR spectrophotometers, titrators, dissolution apparatus and pH meters.
4) Hands on experience with the major pharmaceuticals laboratories data acquisition software. A level of experience related to analytical method transfer, validation and development is an asset.
5) Competencies in teamwork, organization, problem solving and initiative.
6) Good understanding of GMP, USP/BP/Ph.Eur., ICH and FDA guidelines and regulations.
7) Strong oral and written communication skills.

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QC 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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Quality Assurance Associate
• On-line monitoring of processing and packaging operations for Commercial and Clinical Products
• Sampling, testing and releasing of all Raw Materials, Bulk Dosage Form and Packaging Materials
• Incoming material inspections, sampling active / excipient raw materials and bulk drug products
• Review of Batch Records, Finish Product Inspections and Releases
• Updating of Standard Operating Procedures and other departmental documents
• Personal Development
• Other duties as assigned


Position Responsibilities: SCOPE OF POSITION AND MAJOR RESPONSIBILITIES

1. On-line monitoring of processing and packaging operations for commercial and development/clinical products:
• Conducts periodic line inspections of packaging/processing operations
• Ensures that the operations are performed according to SOPs
• Initiates Non-conformance reports for significant deviations noted during inspections
• Obtains required amount of product for lab testing or reserve samples following applicable SOP’s and sampling plans/test methods

2. Sampling, testing and releasing of raw materials, bulk dosage forms and packaging materials:
• Obtains required amount of materials for testing and reserve following applicable SOPs and sampling plans/tests methods
• Consults individual specifications and Sampling SOP for guidance to determine sampling procedures and quantities
• Performs incoming QA Inspection and records results on the specification
• Performs physical inspection/testing on components according to the current Packaging Material Specifications
• Ensures only current, approved printed packaging materials are available for use in production
• Maintains effective communication with Plant Operations to enable performance of tasks and to provide feedback of accomplishments and facilitate resolution of issues
• Performs cleaning of Sampling room in accordance with SOP
• Delivers and logs Sample along with specification to Quality Control Lab for testing
• Update Inventory in ERP System
• Reviews documentation, evaluates and releases all raw materials, bulk dosage forms and packaging material both commercial and development/clinical
• Maintains an adequate supply of sampling containers, utensils and other inventory for sampling activities

3. Performs batch record review, finished product inspection and releases:
• Reviews and evaluates executed batch records (both processing and packaging)
• Performs final inspection of finished product prior to release by assessing product quality and documentation results as required
• Reviews and evaluates 3rd Party documentation
• Ensures compliance with master documents and ANI Pharmaceutical Canada standards for complete and acceptable product batch records prior to release
• Releases processing bulk dosage forms by assessing product quality and documentation results
• Provide for effective and efficient document maintenance


4. Ensures adherence to Heath & Safety by:
• Adhering to all written/ verbal safety and gowning procedures as applicable
• Complying with WHMIS regulations internal safety procedures for the safe handling of chemicals
• Complying with ANI Health & Safety Procedures and Provincial Health & Safety legislation
• Being aware of hazards, reporting them to management and assisting with corrective actions
• Maintaining a safe working environment for self and fellow employees

5. Personal Development:

Develops and maintains knowledge and expertise, and seek to improve skills and effectiveness in all areas of the job, by:

• Maintaining familiarity with GMPs and Standard Operating Procedures applicable to the job
• Developing, with the assistance of the immediate supervisor, an annual training/development plan and periodically reviews this plan to assure consistent with the current development requirements
• Attending and participating in courses as required
• Communicating with peers in various departments to aid in development/implementation of industry standard testing/plans
• Communicating effectively with peers, and other departments to benefit from co-operative skills and knowledge
• Interfacing with other professionals related to the outsourcing industry to improve job performance and enhance job responsibilities


Position Requirements: • Minimum 3 years of experience in a Quality Assurance role within the Pharmaceutical Industry or related experience
• Bachelor of Science degree or equivalent
• Availability to provide QA support during alternative shifts
• In-depth knowledge of current Canadian and U.S. Good Manufacturing Practices
• Ability to perform multiple tasks with excellent competencies in technical writing, oral communications and computer skills
• Strong analytical/decision making skills
• Excellent attention to detail

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Sr. 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.

Position Responsibilities:
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.

Position Requirements:
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.
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Supervisor, Quality Control
This position is responsible for managing and directing, a professional group of chemists engaged in physical and chemical testing of raw materials, packaging components, in-process materials, and finished drug products to determine conformance with specifications. This position is responsible for day to day scheduling of analyst responsibilities to ensure production needs are being met and that the laboratory is in conformance with cGMPs. Additional responsibilities include conducting and writing laboratory investigations, notifying Quality Assurance of potential product quality issues, coordinating contract lab testing, revising SOPs, IOPs and other laboratory related documents. Lastly, this individual enforces company policies and directives that apply to the department

Position Requirements: Minimum Education
• Bachelors Degree in Chemistry, Microbiology, or related field.
• Education, training, or certification in Management and Leadership
Minimum Experience
• 1 year experience in a leadership role in an analytical laboratory in the pharmaceutical industry.
• 4 years experience in an FDA regulated laboratory in the pharmaceutical industry
Minimum Field-of-Expertise
• Ability to follow, prepare and explain technical matters and procedures.
• Ability to make decisions independently after appropriate input from areas that will be affected.
• Ability to manage multiple projects and competing priorities.
• Ability to perform under stressful situations
• Demonstrated expertise of Laboratory cGMPs
• Excellent leadership, communication, and interpersonal skills.
Preferred Education
• Advanced education in Management or Business Administration.
• Post graduate degree with emphasis in Analytical Chemistry, or other relevant area.
Preferred Experience
• 3+ years within the Baudette QC Organization.
• 5 years’ experience in an analytical laboratory in the pharmaceutical industry.

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