Job Description

Department:

85104 Wake Forest University Health Sciences - Academic Translational Imaging Program

Status:

Full time

Benefits Eligible:

Yes

Hours Per Week:

40

Schedule Details/Additional Information:

• 40 hour/week, M-F

Pay Range:

$28.55 - $42.85

JOB DESCRIPTION:

Develops, implements methods, and performs manufacturing of PET radiopharmaceuticals in a GMP environment for preclinical and clinical PET imaging research. Performs and develops a variety of chemistry-based operations, including organic and analytical. Performs validation and verification of equipment and procedures

EDUCATION/EXPERIENCE:

• Bachelor's degree in Chemistry, Chemical Engineering, or closely related field with specific training or coursework in Organic or Inorganic Chemistry, or Pharmacology. Academic training or experience in analytical methods, chemical synthesis, or Good Manufacturing Practices (GMP) methods is preferred.

ESSENTIAL FUNCTIONS:

• Executes manufacturing of radiopharmaceutical productions for preclinical and/or clinical research in the GMP lab facility, following all the radiation safety protocols under the supervision of the PET Center Director.
• Training will be provided to perform the radiochemistry and QC operations following all safety protocols.
• Uses specialized education and training to support process development and develops methods for analysis of process intermediates and final products.
• Develops, implements and follows standardized operating procedures (SOPS) for all the different steps for performing various production parameters.
• Writes, revises and executes batch records following cGMP documentation guidelines and follows SOPs in support of projects/processes that move into the GMP facility.
• Attends internal and external seminars, training sessions and workshops to maintain competency in evolving current radiopharmaceutical productions, regulations and job functional requirements.
• Operates a variety of equipment including analytical instruments including HPLC, GC, biosafety cabinets incubators and chemistry hoods and radiochemistry hot cells. Assists in performing equipment and process validation, verification, qualification. Troubleshoots equipment and manufacturing processes actively.
• Maintains GMP cleanroom environment by performing scheduled cleaning of equipment and/or manufacturing areas as needed.
• Write SOPs and maintain detailed lab notes and batch records of all the experiments.
• Takes initiative to identify opportunities for process improvement and implementation.

SKILLS & QUALIFICATIONS:

• Strong oral and written communication skills.
• Experience in chemistry synthesis, with at least some academic training in basic chemistry and analytical separations of small molecules.
• Excellent recordkeeping and documentation skills.
• Understanding of Microsoft Excel, Word, and ability to master other laboratory analytical computer software. Outstanding interpersonal skills, high energy and motivated.

WORK ENVIRONMENT:

The Translational Imaging Program (TIP) is fee-for-service core unit that carries all the research imaging at the Advocate Wake Forest including PET/CT, MRI and CT scanning, and PET radiotracer manufacturing processes for both preclinical and clinical imaging research studies in compliance with the current good manufacturing practice regulations (cGMP) as well as the other applicable regulations.

The TIP lab consists of ISO 5 and ISO 7 classified cleanroom space along with an external Quality Control Lab, store house, scanner and process development laboratories. Access to all classified areas requires appropriate gowning and aseptic techniques.

PHYSICAL REQUIREMENTS:

This position often requires many hours per day in full cGMP gowning with facemask, hood, and double gloves, within areas of limited mobility, while performing meticulous manual work requiring attention to detail.

Amount of time spent performing the following activities:

Our Commitment to You:

Advocate Health offers a comprehensive suite of Total Rewards: benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more – so you can live fully at and away from work, including:

Compensation

• Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training
• Premium pay such as shift, on call, and more based on a teammate's job
• Incentive pay for select positions
• Opportunity for annual increases based on performance

Benefits and more

• Paid Time Off programs
• Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
• Flexible Spending Accounts for eligible health care and dependent care expenses
• Family benefits such as adoption assistance and paid parental leave
• Defined contribution retirement plans with employer match and other financial wellness programs
• Educational Assistance Program

Note: Eligibility for programs listed above may depend on your FTE or status (e.g., full-time, part-time, per diem, temporary, etc.); please ask a Recruiter for more information during an interview.

About Advocate Health

Advocate Health is the third-largest nonprofit, integrated health system in the United States, created from the combination of Advocate Aurora Health and Atrium Health. Providing care under the names Advocate Health Care in Illinois; Atrium Health in the Carolinas, Georgia and Alabama; and Aurora Health Care in Wisconsin, Advocate Health is a national leader in clinical innovation, health outcomes, consumer experience and value-based care. Headquartered in Charlotte, North Carolina, Advocate Health services nearly 6 million patients and is engaged in hundreds of clinical trials and research studies, with Wake Forest University School of Medicine serving as the academic core of the enterprise. It is nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics and rehabilitation, as well as organ transplants, burn treatments and specialized musculoskeletal programs. Advocate Health employs 155,000 teammates across 69 hospitals and over 1,000 care locations, and offers one of the nation’s largest graduate medical education programs with over 2,000 residents and fellows across more than 200 programs. Committed to providing equitable care for all, Advocate Health provides more than $6 billion in annual community benefits.