Description
Position Overview
This position is responsible for performing compounding and compressing of GMP commercial batches.
Key Responsibility Areas
* Quality: Ensures the quality of work, products and services as a first priority; complies or exceeds all regulatory and cGMP compliance standards as well as ensure accuracy of analyses as it relates to right first time measures
* Safety: Adheres to all workplace safety laws, regulations, standards, and practices and actively advances a culture of safety within their team and organization
Specific Responsibilities
Responsibilities include, but are not limited to:
* With minimal supervision, assist in the manufacture of scale-up, biobatch and full commercial scale batches and development and CTM batches
* With minimal supervision, assemble, disassemble, clean and store manufacturing equipment
* Ensure that all work is accurate, precise, properly documented, compliant with SOPs and FDA cGMP guidelines
* With supervision, document batch manufacturing in batch records accurately and completely as required
* Perform and witness manufacturing steps
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
Qualifications
* High school diploma or equivalent with at least six years of pharmaceutical industry experience
* Associate degree in Applied Science with four years of equivalent pharmaceutical industry experience
Physical Requirements
* Position requires the ability to lift in excess of 50 lbs unassisted
* Majority of work day is performed while standing, walking, lifting, pulling, pushing
* Requires the use of hands for simple grasping and fine manipulations
* Requires bending, squatting, reaching, pushing, climbing
* Requires the ability to stand for extended periods of time
* Some exposure to hazardous chemical and other active chemical ingredients
* 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.
