Description
Position Overview
This position is responsible for the dispensing, compounding, compressing, encapsulating, tablet coating and printing of good manufacturing practice (GMP) commercial batches in an oral solid dosage (OSD) environment.
The work schedule for this position is Monday through Thursday -- 4:00 pm to 2:30 am. There is potential for Friday scheduling depending on business needs.
Key Responsibility Areas
* Good Documentation Practices: Ensure accurate and compliant documentation is maintained for all manufacturing batches
* Manufacturing Equipment Maintenance: Complete the assembly, disassembly, cleaning, and storage of manufacturing equipment
* Manufacturing Training: Provide technical training for a specialized selection of manufacturing training protocols including, but not limited to, dispensing, compounding, compressing, encapsulating and tablet coating
* OSD Equipment Operation: Operate machinery to develop and manufacture scale-up, bio-batches, CTM batches and full commercial scale batches
Specific Responsibilities
Responsibilities include, but are not limited to:
* Independently assemble, disassemble, clean and store manufacturing equipment
* Ability to troubleshoot machinery and equipment and recommend corrective or preventative measures
* Ensure all batch records and logbook entries are accurately documented and compliant with SOPs and FDA cGMP guidelines
* Monitor operations for deviations, mechanical issues, and quality assurance
* Conduct setup, changeover, and manufacturing activities with adherence to SOPs and safety requirements
* Escalate and work to resolve any production, quality or safety issues
Key Competencies/Requirements
* Accountability: Assume responsibility for successfully accomplishing work objectives and delivering business results; setting high standards of performance for self and others
* Agility: Respond positively to change, embracing and using new practices or values to accomplish goals and solve problems
* Creativity: Explore and advances opportunities to develop novel solutions and approaches to the improvement of processes and services
* Empowerment: Find opportunities to improve and extend their contribution to the organization and their teammates
* Integrity: Demonstrate the highest commitment to integrity and showing respect for and value all individuals for their diverse backgrounds, experiences, styles, approaches and ideas
* Passion: Evidence passion for the organization, our people, and the difference we make daily in improving the lives and health of people
* Attention to Detail: Ensure information is complete and accurate; follow up with others to ensure that agreements and commitments have been fulfilled
* Task Management: Plan work well, maintain flexibility and facilitate change when needed while optimizing quality and productivity
* Teamwork: Work well with others while providing support and assistance to team members to help accomplish objectives
Qualifications
* High school diploma or equivalent with at least 3 years of experience in pharmaceutical OSD manufacturing
* Associate degree with at least 2 years of experience in pharmaceutical OSD manufacturing
* Demonstrated proficiency with manufacturing skills, processes and equipment knowledge to serve as a trainer to provide specific technical training on processes and equipment with minimal guidance
* Required to obtain internal forklift operation certification
Physical Requirements
* Position requires the ability to lift 50 lbs unassisted, and push and pull in excess of 100 lbs
* Majority of work day is performed while standing and walking
* Requires the use of hands for simple grasping and fine manipulations
* Ability to occasionally bend, stoop, twist, and have full range of motion in upper and lower extremities
* Exposure to hazardous chemicals, other active chemical ingredients, dust, fumes, gases, skin and respiratory irritants, moving machinery parts, and damp, humid and wet environments
* Must be able to use a variety of tools, equipment, and machinery
Equal Employment Opportunity and Employment Eligibility
Mayne Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. Mayne Pharma also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Mayne Pharma is an E-Verify employer.
