Mikart's employees are fundamental to the foundation of our success, and our staff plays an integral role in building longstanding and profitable customer relationships. We are committed to hiring and retaining high quality professionals.
Mikart offers an excellent benefits package from date of hire. The company fosters an open door management policy and building close-knit teams. We stress balance between our employee's personal and professional life, and foster a friendly, yet professional, work environment using advanced technology in state-of-the-art facilities. Continuous pursuit of improvement underscores all that we do.
Our comprehensive benefits plan includes:
- 401(k) Profit Sharing Plan with salary deferrals, company match and discretionary profit sharing contributions
- 100% company-paid short- and long-term disability coverage
- 100% company-paid basic life insurance
- optional supplemental life insurance
- group health insurance, including medical and dental coverage
- Vision care coverage
- Medical Care Spending Account to help bridge the gap between health care expenses covered by insurance and eligible expenses that are paid out-of-pocket, by setting aside a certain amount of pretax dollars each year
- Dependent Care Spending Account to help cover eligible out-of-pocket expenses for child or elder care, by setting aside a certain amount of pretax dollars each year
- Employee Assistance Program to provide employees and their families resources and referrals on such issues as child, elder and self care, financial and legal matters
- 11 paid holidays
- Paid Time Off (PTO) earned at rates of 16 days - 26 days per year, based on length of service
The involvement, dedication, and teamwork of our people support our efforts to grow and prosper. If you are interested in pursuing employment at Mikart, please see below for our current list of career opportunities.
Quality Assurance Associate
Analytical R&D Manager
Formulations Research Scientist
Analytical R&D Senior Scientist
Experienced Compression Technician
Quality Control Chemist
Quality Assurance Associate:
As a QA Associate, you will responsible for continuously monitoring the in-process manufacturing and packaging operations to assure that all products meet established specifications. Duties include the following:
• Monitor Quality Assurance Assistants and plant personnel and operations to assure that all operations are performed in accordance with master instructions, CGMPs, and Standard Operating Procedures.
• Assure that all monitored parameters for production and packaging are within specifications, and that checks are conducted and documented promptly and accurately. Notify QA Manager to initiate investigations into oos results as required.
• Perform clean room or equipment clearance inspections for production and packaging areas, materials, and equipment when requiered.
• Perform in-process testing of tablets, capsules and liquids for manufacturing including weight variation, hardness, thickness, friability, disintegration, pH, moisture content and organoleptic testing.
• Obtain labeling materials for packaging upon request of the Packaging Department. Review and approve labeling materials prior to release to Packaging Department for use.
• Program check weighing balance used to verify contents of shippers.
• Complete specifications for Packaging Department as necessary to process products.
• Check counts, weight variation, torques, and physical appearance for products throughout the packaging process. Verify that packaged product corresponds with requirements as stated on the packaging master. Prepare bulk labels as needed.
• Obtain samples of finished products to be held as retainers. Collect and submit finished products samples as required by packaging masters and specifications.
• Weigh rejected materials and waste from Quality Assurance testing and from others departments. Document weights in the batch records and rejected materials log as appropriate. Assist in the maintenance of the rejected materials storage areas.
• Assure that all logbooks, manufacturing records, and other official documents are completed in an accurate and timely manner.
• Perform review and reconciliation of master records upon completion of operations. Calculate yields after processing steps as required. Generate and/or complete documentation required for final Quality Assurance review and release.
• Assist Quality Assurance Supervisor, Quality Assurance Manager, and Assistant Manager in other areas as directed.
Requirements for the position include:
High School diploma, or equivalent, with one year of Quality Assurance experience. Another combination of education and experience may be considered. Fluency in the English language and good mathematical skills are required. Must be available to work flexible schedule of either 7:00am to 3:30pm or 2:00pm to 10:30pm and overtime as needed.
Analytical R&D Manager:
The Manager for Mikart's Analytical R&D Department directs, organizes, coordinates and monitors the activities of the Analytical lab, and provides technical support, leadership and guidance to the Analytical R&D laboratory staff. Responsibilities include:
• Coordinate and monitor the work flow of method development and validation projects, sample testing and transfer of methodology through the Analytical department to Quality Control;
• Oversee supervision of lab employees and scheduling of workload priorities to ensure maximum lab efficiency, timely and profitable completion of laboratory projects;
• Provide technical guidance and project support for the AR&D laboratory staff;
• Oversee training and professional development of AR&D staff;
• Ensure proper use and maintenance of laboratory equipment, compliance with all SOPs, cGMPs, and government regulations;
• Maintain and manage cGMP and controlled substance systems in Analytical Development at defined levels of compliance;
• Oversee purchase of analytical instrumentation and other budgetary requirements;
• Review and approve methods and technical reports for clarity and accuracy;
• Draft and review SOP's, protocols, reports and other various documents in support of analytical development efforts;
• Communicate with clients to plan and execute project deliverables.
Requirements for the position include:
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Minimum of Bachelor's (Master degree preferred) degree in Chemistry or related scientific field with at least 7 years of Analytical Chemistry, including 3 years of managerial experience; an advanced degree is preferred.
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Pharmaceutical laboratory experience, preferably in contract manufacturing organization, with strong, demonstrated expertise in analytical method development and validation for solid dosage forms is required.
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Hands-on bench experience with laboratory instrumentation and technologies (HPLC, GC, UPLC) and FDA submissions, comprehensive knowledge of Part 11 compliance and USP as applied to pharmaceuticals a must.
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Strong background in quality control preferred.
Formulations Research Scientist:
As a member of our Formulation Development team you will assist with the research and development activities associated with the development of novel formulations and reformulations of prescription pharmaceutical forms (solid and liquid oral dosage forms). You will be expected to utilize existing technologies available within the industry and assist with the development or location of new technologies that will be of interest to and will support the company's product development initiatives and objectives with regard to new products and dosage forms. Additional responsibilities include evaluation of product stability and scale-up of formulations in our GMP production facility.
BS degree in Chemistry or related science is required. MS in Industrial Pharmacy is a plus. Minimum of 3 years proven ability to execute product deliverables, from conceptualization, excipient compatibility, R&D formulation, to batch manufacturing, required. Hands-on, bench formulation and process/scale-up experience in non-sterile dosage forms (tablets, capsules, liquids), development of modified dosage forms, use of direct compression, high shear granulation, roller compaction and fluid bed technology, and various tableting and coating processes, is expected. Formulation experience of generic drug products is a must.
The ideal candidate will be adaptable and creative, and will be highly motivated working in an environment where the creative input of the scientist is sought and encouraged in the development of new technologies to enhance drug delivery. Excellent oral communication and technical writing skills are necessary.
Analytical R&D Senior Scientist:
As a member of our Analytical R&D Lab, you will be responsible for the development and validation of methods for products developed by the internal formulations group, primarily in prescription pharmaceutical forms (solid and liquid dosages).
BS degree in Chemistry is required. MS desired. Minimum of 5 years of experience in a pharmaceutical laboratory required. Candidates will be expected to independently provide project support for all analytical activities in pre-formulation research, product development, method development, method validation, product testing, and FDA submissions. Hands-on, bench experience in active and related substance separations by HPLC and GC is a must. Excellent oral communication and technical writing skills are necessary.
Mikart strives to be a leader in new technology. As such, the R&D department has acquired multiple Water Acuity UPLC systems. Candidates will be expected to learn and develop procedures by the new UPLC technology. Experience in UPLC is a plus.
Experienced Compression Technician:
Experience should include:
1. Operation and maintenance of instrumented high-speed tablet presses and encapsulation machines, specifically Kikasui, Fette, Manesty, SeJong, Korsch, Bosch, Index, Shionogi;
2. Troubleshooting encapsulation and compression processing challenges;
3. Operation and assembly of non-instrumented tablet presses;
4. Operation and assembly of instrumented encapsulation machines;
5. Assembly and operation of multiple layer tablet production;
6. Ability to troubleshoot routine encapsulation processing challenges;
7. Working with scientists on new and scale up products;
8. Performing compression or encapsulation duties in accordance with company procedures and applicable regulations;
9. Assuring that all compression and encapsulation equipment meets or exceeds acceptable operating standards;
10. Troubleshooting equipment and performing routine and none-routine maintenance on compression and encapsulation equipment;
11. Providing technical support to the department as needed.
Experience in a pharmaceutical manufacturing environment is a must. High school diploma or equivalent, with good mathematical skills and a mechanical aptitude required. Fluency in the English language is required. Must be able to perform required repetitive lifting tasks. Computer literacy preferred.
Quality Control Chemist:
The QC Chemist for Mikart, Inc. is responsible for preparing, performing, and documenting analyses on incoming in-process, raw material, finished product, and/or stability samples in accordance with Mikart specifications and procedures. General analyses include:
1. The use of all laboratory equipment used in routine sample analyses (for example, UV-VIS, FTIR, Karl Fischer Titrator, pH meter, drying oven, and dissolution apparatus for finished product and stability testing),
2. The use and operation of HPLCs equipped with integrators, and with Millennium software,
3. Sample prep for GC analyses, and the use and operation of GCs equipped with Chemstation software,
4. Participation in discrepancy investigation resolution procedures.
BS degree in Chemistry is required. Minimum of 2 years of experience in a pharmaceutical laboratory preferred; or other appropriate combination of education, training and applicable experience.
Qualified applicants should submit their resumes with salary history to careers@mikart.com as an attachment in Word (*.doc) format or fax to 404-350-0432, attention HR.
STARTING SALARY FOR THE ABOVE POSITIONS IS COMMENSURATE WITH EXPERIENCE.
Preferred consideration will be given to candidates with previous pharmaceutical industry experience.
We are a drug-free workplace. All successful candidates will be subject to drug testing
Paper resumes may be mailed to:
Human Resources
1750 Chattahoochee Ave., NW
Atlanta, GA 30318
PLEASE NO PHONE CALLS OR AGENCIES
EEO M/F/D/V
