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.
Open Positions:
Chemist - Quality Control Analyst
Analytical R&D Assistant Scientist
Analytical R&D Method Development Associate Scientist
Qualifications Engineer
Compression Technician
Manufacturing Manager
Quality Assurance Cleaning Validation and Calibration Specialist
Chemist - Quality Control Analyst:
The QC Analysts for Mikart, Inc. are 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:
• The use of all laboratory equipment used in routine sample analyses (for example, UV-VIS, FTIR, Karl Fisher tritator, pH meter, drying oven, and dissolution apparatus for finished product and stability testing).
• The use and operation of HPLCs equipped with integrators, and with Millennium software.
• Sample prep for GC analyses, and the use and operation of GCs equipped with Chemstation software.
• 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.
Analytical R&D Assistant Scientist:
As a member of our Analytical R&D Lab, you will perform GMP testing on incoming stability samples, primarily comprised of prescription pharmaceutical dosage forms (solid and liquid oral dosages). General analyses include:
• Use of various laboratory equipment for routine sample analyses (e.g., HPLC, UPLC, GC, UV-VIS Spectrophotometer, Dissolution Apparatuses, Karl Fisher titrator, etc.
• Operation of HPLCs and GCs using Empower 2 software.
• Participation in discrepancy investigation resolution, as required.
• Providing project support for analytical activities in method transfer, pre-formulation research or method validation, as needed.
Minimum requirements include a BS degree in Chemistry and 2 years experience in a GMP pharmaceutical laboratory environment. Hands-on, bench experience with HPLC and GC is a must. Excellent communication and technical writing skills are required.
Mikart strives to be a leader in new technology. As such, the R&D department has acquired multiple Water Acquity UPLC systems. Experience in UPLC is a plus.
Analytical R&D Method Development Scientist:
As a member of our Analytical R&D Lab, you will perform method development studies, primarily for drug substances and prescription pharmaceutical dosage forms (solid and liquid oral dosages). General responsibilities include:
• Independent investigation of literature and compendial sources to define an appropriate basis for analysis.
• Conduct method development activities as directed in a timely and efficient manner.
• Document development activities, and draft specifications and procedures as appropriate.
• Collaborate with formulators and method development chemists as needed to facilitate project completion.
• Use of various laboratory equipment for routine sample analyses (e.g., HPLC, UPLC, GC, UV-VIS Spectrophotometer, Dissolution Apparatuses, Karl Fisher titrator, etc.
• Operation of HPLCs and GCs using Empower 2 software.
• Providing project support for analytical activities in method transfer, pre-formulation research or method validation, as needed.
Minimum requirements include a BS degree in Chemistry and five years experience in a GMP pharmaceutical laboratory environment, including a minimum of three years experience in method development. Hands-on, bench experience with HPLC and GC is a must. Excellent communication and technical writing skills are required.
Mikart strives to be a leader in new technology. As such, the R&D department has acquired multiple Water Acquity UPLC systems. Experience in UPLC is a definite advantage.
Qualifications Engineer:
The Qualifications Engineer for Mikart is responsible for assuring that new and existing equipment and facilities are properly installed and qualified for use. This individual is also responsible for providing sampling procedures for the cleaning validation program. The Qualifications Engineer position reports directly to the Manager of Engineering. Duties include:
• Write, execute and create final reports for Installation Qualifications (IQs), Operational Qualifications (OQs) and Performance Qualifications (PQs) on equipment.
• Write Standard Operation Procedures (SOPs) and Standard Maintenance Procedures (SMPs) for equipment. Train operators on procedures.
• Prepare cleaning validation sampling protocols.
• Maintain equipment list and assign asset numbers.
Qualifications: BS in Industrial Engineering, Mechanical Engineering or applied science and a minimum of 2 years of experience in a GMP environment, or other appropriate combination of education and experience. Sound knowledge of principals and applications of cGMP’s and associated regulations in a pharmaceutical setting a plus. Must display attention to detail, excellent organizational skills and the ability to handle multiple priorities. Fluency in the English language, well-developed technical writing skills, ability to work in a team environment and demonstrated effective written and oral communication skills required.
Compression Technician:
The Compression Technician for Mikart is responsible for the duties performed as part of the process of generating quality finished solid dosage forms. The successful candidate will have a strong commitment to cGMP and safety procedures, and should be skilled in the following activities:
• Assembly, tooling, and operation of machinery such as Sejong, Fette, Manesty, Shionogi, Bosch and Elanco-Fill, and multi-layer presses.
• Extensive experience assembling, tooling and operating Fette machine required.
• Ability to troubleshoot routine compression and encapsulation challenges.
• Performance of various checks and inspections during processing.
• Performance of routine and non-routine maintenance on equipment.
• Ability to contribute to and support the technical needs of the department.
• Knowledge of proper disassembly and cleaning techniques.
Requirements for the Position:
Manufacturing Manager:
The Manufacturing Manager is responsible for the direct supervision of personnel in either the Compression/Coating/Granulation departments or the Pharmacy/Blending/Liquids departments, and meeting or exceeding the productivity standards for the department. Responsibilities include the following:
• Staffing the department with appropriate personnel and supervising the work performed.
• Training personnel in proper procedures for cleaning and maintenance of work areas, and operations performed. Assuring that all production personnel perform duties in accordance with Mikart's regulations, batch instructions, cGMPs, and Standard Operating Procedures.
• Training production personnel in safety procedures, and maintaining the production areas in accordance with generally accepted safe operating standards.
• Sampling controlled substances and supervising the transfer of controlled substances entering or leaving manufacturing areas.
• Assuring that all logbooks, manufacturing records, and other official documents are completed in an accurate and timely manner. Reviewing master records for correctness and completeness for batches processed by manufacturing personnel.
• Developing all SOP's required for operation, cleaning, and maintenance of any equipment used for processing in the department.
• Developing and implementing procedures to improve productivity and quality. Participating in the identification, sourcing, and qualification of new or replacement equipment required to accomplish production goals.
Requirements for the Position:
Bachelor's degree and five years manufacturing experience, or other appropriate combination of education and experience. Demonstrated leadership ability and good organizational skills. Fluency in the English language is required.
Quality Assurance Cleaning Validation and Calibration Specialist:
The QA Cleaning Validation and Calibration Specialist is responsible for maintaining the Cleaning Validation and calibration programs and for ensuring that all plant operations are being conducted in accordance with applicable regulations. Responsibilities include the following:
• Maintaining the Cleaning Validation through the following activities:
- Preparing Cleaning Validation assessments, protocols or other related documents.
- Preparing drug substance and drug product assessments
- Preparation of Cleaning Validation product assessments
- Scheduling and performing sampling activities
- Preparing study reports and updating tracking or other data spreadsheets
- Developing or modifying related SOPs
- Tracking of existing and new requirements
- Conducting internal evaluations on the performance and compliance of the Cleaning Validation Program
• Developing protocols and reports for method validation studies related to the Cleaning Validation Program.
• Assisting in the review of plant documentation such as equipment qualifications, SOPs, and other documents as related to Cleaning Validation program.
• Administer the calibration system including work order issuance and data entry, maintenance of documentation, re-certification of standards and scheduling contract personnel where applicable.
• Provide support during plant audits by customers and government agencies, as required.
Requirements for the position:
Bachelor's degree in one of the sciences, Microbiology degree is preferred. Three years of related experience, including experience in cGMP compliance, FDA regulations or other appropriate combination of education, training, and experience. Must have excellent organizational, interpersonal, written and verbal communication skills.
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
