Manufacturing Specialist

COMPANY OVERVIEW

ESSENTIAL FUNCTIONS

• Carries out production responsibilities to meet manufacturing schedules.
• Performs chemistry manipulations for production in a GMP environment.
• Ensure regulatory compliance of production protocols within the manufacturing operations.
• Analytical methods and procedures for testing of GMP manufactured radiopharmaceutical products.
• Prepare and submit required reports.
• Supporting and executing deviation reports, OOS, root cause investigations and CAPA.
• Optimize and validate methods and procedures for radiopharmaceutical products.
• Assist with creating SOPs for use in production.
• Assist with the preparation of regulatory submissions.
• Assist with general lab cleaning, supplies and maintenance.
• Assist with waste management.
• Performs other related duties as assigned.

KNOWLEDGE-SKILLS-ABILITIES

• Physical Ability – Be able to lift 50 pounds with no restrictions.
• Customer and Personal Service - Knowledge of principles and processes for providing customer and personal services. This includes customer needs assessment, meeting quality standards for services, and evaluation of customer satisfaction.
• Active Listening - Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.

• Speaking - Talking to others to convey information effectively.

• Critical Thinking - Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems.

• Time Management - Managing one's own time and the time of others.

• Active Learning - Understanding the implications of new information for both current and future problem-solving and decision-making.

• Coordination - Adjusting actions in relation to others' actions.

• Oral Comprehension - The ability to listen to and understand information and ideas presented through spoken words and sentences.

• Oral Expression - The ability to communicate information and ideas in speaking so others will understand.

• Written Comprehension – The ability to read and understand information and ideas presented in writing.

• Written Expression - The ability to communicate information and ideas in writing so others will understand.

• Deductive Reasoning - The ability to apply general rules to specific problems to produce answers that make sense.

TRAVEL

• Regular travel is minimal

REQUIRED EDUCATION AND EXPERIENCE

• Prior experience in pharmaceuticals, preferably in a quality or production position is ideal. Prior experience in a radiopharmaceutical environment a plus.
• Excellent communication, analytical, computer/PC and technical writing skills.
• The ability to handle responsibilities in a fast-paced manufacturing environment.
• Demonstrated ability to work as part of a team.
• Thorough understanding of project management.
• Excellent organizational skills and attention to detail.

PREFERRED EDUCATION AND EXPERIENCE

• A Bachelor’s Degree in Chemistry, Biochemistry, Chemical Engineering, or a related field.
• An Associate’s Degree in these areas, along with a minimum of 2 years of related experience in a pharmaceutical manufacturing environment (with preference to radiopharmaceuticals) may be considered.
• Aseptic processing experience preferred.
• Excellent communication, analytical, computer/PC and technical writing skills.

• Ability to train and be trained.

ADDITIONAL REQUIREMENTS

• Valid Indiana driver's license

• Pass a Background Check.

ADDITIONAL INFORMATION/BENEFITS

• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

• We recognize that people come with a wealth of experience and talent beyond just the technical requirements of the job. If your experience is close to what you see listed here, please still consider applying. Diversity of experience and skills combined with passion is a key to innovation and excellence; therefore, we encourage people from all backgrounds to apply to our positions. Please let us know if you require accommodations during the interview process.

• We are an equal opportunity employer. Qualified applicants shall be considered for all positions without regard to race, color, sex, religion, national origin, age, disability, veteran status, or any other status protected by federal, state or local law. Refusal to submit to testing will result in disqualification of further employment consideration.