Gmp Manufacturing Scientist Jobs

Clear leadership qualities and demonstrated success in management of change.

Ability to develop strategic relationships; strong verbal and written communication skills; excellent presentation skills.

Excellent computer skills and proficient in MS Office (Word, Excel, Outlook, PowerPoint).

Experience prolonged sitting, some bending, stooping and stretching.

Lean Six Sigma – Black Belt Certification

Working Conditions & Physical Requirements:

Previous industry experience that provides the knowledge, skills, and abilities to perform the job:

Shows initiative; acts independently with management approval.

Ability to perform method development transfers and qualifications.

Improving the laboratory—including managing reagents, materials, improving lab flows, et cetera—with minimal managerial support.

Bachelor''s degree or equivalent and relevant formal academic / vocational qualification

Experience in a commercial QC lab setting.

Escalation and management of program execution gaps

Respond to detailed inquiries, and present information to groups and senior management.

Align program requirements (Global, GMP, continuous improvement)

Demonstrate interpersonal and leadership skills with the ability to work with well with other departments, and lead in a team environment.

Manage various processes in a manufacturing plant setting.

Experience with GMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry.

Minimum Qualifications – Education And Experience

Preferred Qualifications – Education And Experience

Other projects or responsibilities as may be required.

M.S. with generally more than 8 yrs of relevant working experiences.

Ph.D. with generally 2-4 years of post-doctoral training or relevant working experiences

Experience in process development and optimization for stem cells and/or hybridoma cell culture

Required Education, Experience and Certifications:

· Ability to influence senior management, peers and other colleagues without direct reporting lines

** Note: Prior Pharmaceutical / Biotechnology Experience Required

· Previous virtual manufacturing / CMO Oversight experience preferred

Domestic and International travel up to 25% of time may be required

· Ensure all API, drug product and investigational product batches are released on time

Additional responsibilities not listed may be assigned as needed by management.

Plans work to meet production and schedule requirements from clients (internal and external).

Bachelor’s Degree (B.A. or B.S.) in Biology, Biochemistry, Biomedical Engineering or related life science field (or equivalent experience)

Strong technical aptitude, including demonstrated experience in applying scientific reasoning to solve complex problems.

Working knowledge of cGMP and ISO guidelines

Wellness benefits (financial planning services, mental health counseling, employer paid disability)

Manages the day to day materials, equipment, and other resource requirements to maintain Drug Product output.

Supports the management of external, technical interfaces to external manufacturing organizations.

Experience and well-developed understanding of process development approaches related to drug product.

Technical understanding and experience in biopharmaceutical process manufacturing operations and tech transfer to external organizations.

Strong interpersonal, organizational, and communication skills are required for this role.

Knowledge of GxP regulations and QbD principles are helpful.

Working knowledge and understanding of chemistry and analytical technologies.

Understanding of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs and descriptive organic chemistry.

Satisfactory interpersonal (both oral and written). Good presentation skills to present information to our clients, other departments and other laboratory employees.

Experience performing chemical tests with chromatographic, spectroscopic, or other analytical technique preferred.

Verify and pre-validate logical and rational testing in preparation for method transfer to our Commercial facilities at the Cincinnati site.

Develop and validate methods to test pharmaceutical finished products for strength, identity, impurities and dissolution performance by commonly used techniques.

Strong time management, communication and critical thinking skills.

Two (2) or more years of related experience.

Experience in statistics, artificial intelligence, data analytics and machine learning.

Strong presentation skills and ability to confidently interface internal or external customers.

Highly organized and detail-oriented, with strong critical thinking, analytical, and problem-solving skills.

Automotive or heavy duty on or off-road vehicle, digital data bus, including Ethernet or Controller Area Network (CAN) experience.