Location: Greenville,NC, USA
**Description**
**Position Overview**
This position leads laboratory personnel in daily activities providing coaching and feedback to team members. This role provides laboratory support for internal business units and external client pre-commercial and commercial processes and projects.
**Key Responsibility Areas**
* **Exception Management:** Initiate and perform investigations for out-of-specification and out of trend results as well as deviations from standard operating procedures; ensure timely and comprehensive investigations in compliance with established internal procedures
* **People Development:** Support development and growth of chemists/scientists in GMP good documentation practices, understanding client project scope, and laboratory technical skills sets by providing on-the-job training, mentoring and guidance
* **Quality:** Ensure the integrity of data, 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:** Adhere to all workplace safety laws, regulations, standards, and practices and actively advance a culture of safety within his or her team and organization
* **Testing Support:** Lead the planning, scheduling, and communication of all required laboratory analytical testing to ensure the highest levels of efficiency and quality standards are met with occasional testing within the laboratory to keep programs on tract
**Specific Responsibilities**
Responsibilities include, but are not limited to:
* Supervise, guide and oversee learning and development needs for a team of approximately 3 to 6 scientists and other laboratory personnel at various levels
* Resolve conflicts within the group relating to performance and/or workload as well as ensure proper resource allocation within and across teams
* Schedule analytical work and review analytical data packets and analysis reports, as appropriate
* Responsible for development and performance management of direct reports including training, coaching and mentoring
* Lead in the development of a climate of quality and safety within the teams, by identifying and monitoring quality and safety standards
* Ensure all work is performed and documented according to approved standard operating procedures, in general compliance with cGMPs and in a timely manner consistent with agreed upon schedules
* Maintain proficiency in process and data review within respective scientific field of operation in accordance with job responsibility and function, able to troubleshoot instrument, method and technique-related issues
* Perform comprehensive and structured investigations for out of specification results or deviations utilizing company procedures and established root cause analysis techniques
* Identify and recommend opportunities for improved efficiencies, customer service, and teamwork within the analytical group as well as monitor key performance indicators
* Project management and serve as Analytical representative for internal and external clients, both commercial and pre-commercial and, as required, CMOs
* Develop, evaluate, validate, verify or otherwise qualify compendial and non-compendial methods and procedures for excipients, actives, finished products and packaging components
* Solve problems with methods, instruments, products or processes; interpret and trend data generated, escalate notification procedures as appropriate
* Author and review analytical procedures, validation documents, portions of regulatory submissions for site pre-commercial and commercial projects relating to Analytical
* Correctly operate and maintain laboratory equipment, foresight relating to recommending replacement or upgrade to better meet business needs
* Ensure compliance to all compendial, internal and client-specific requirements (SOPs, Quality Agreements, General and Informational Chapters in multiple compendia as applicable)
* Serve as a liaison to other teams in the coordination of resources and sharing of best practices across teams
**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
* **Teamwork:** Work well with others while providing support and assistance to team members to help accomplish objectives
* **Time Management:** Establish a systematic course of action for self or others to ensure accomplishment of a specific objective; set priorities, goals, and timetables to achieve maximum productivity
**Qualifications**
* Associate degree in Biotechnology, Chemistry or equivalent science degree with 9 years of professional experience in pharmaceutical analytical chemistry
* BS or BA degree in a science-related field (e.g. Biology, Chemistry, Pharmaceutical Sciences) with 8 years of professional experience in pharmaceutical analytical chemistry
* Masters degree in a science-related field with 6 years of professional experience in pharmaceutical analytical chemistry
* PhD in a science-related field with 4 years of relevant experience in pharmaceutical analytical chemistry
**Physical** **Requirements**
* Majority of work day is performed while standing, walking, lifting, pulling, pushing
* Requires the ability community effectively using speech, vision and hearing
* Requires the use of hands for simple grasping and fine manipulations
* Requires the ability to stand for extended periods of time
* Some exposure to hazardous chemical and other active chemical ingredients
**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.