Careers - CoreRx®

Careers

TECHNOLOGY TRANSFER ASSOCIATE

Job Title
TECHNOLOGY TRANSFER ASSOCIATE
Job ID
27663984
Location
Clearwater,  FL 33760
Other Location
Description

This position is currently unavailable. CoreRx is collecting applications for a role opening in Q4 of 2022.

WHY CORERX?
CoreRx is a dynamic pharmaceutical technology company that empowers its employees with responsibility and offers a supportive and highly progressive work environment. At CoreRx, our biggest asset is our people, and the service and solutions they provide to our partners; you will find a challenging career path directed towards growth and opportunity. We employ talented, motivated people – team players who are innovative thinkers. We offer our employees a comprehensive, competitive program of benefits and a corporate culture based on core values that include innovation, a results-oriented focus, and ethical behavior.

Our employees enjoy a competitive benefits package, including:

  • Competitive compensation with an annual discretionary incentive bonus!
  • Affordable healthcare insurance (Medical, Dental, Vision)
  • Health Care Flexible Spending Account
  • Employer paid LTD, STD, and Life Insurance coverage.
  • Paid Time Off (PTO), 15 days pro-rated your first year + 10 Paid Holidays.
  • 401k with 100% employer match
  • Tuition Reimbursement, Perks at Work Employee Discounts, Employee Assistance Program, and Adoption Assistance Program.
GENERAL POSITION DESCRIPTION
​​​​The Technology Transfer Associate will work with Formulation Scientists and Manufacturing personnel to facilitate the transfer / scale-up of manufacturing processes from the development laboratory to clinical manufacturing scale.  The Associate will actively participate in the planning and execution of technology transfer activities and in the training of manufacturing personnel on the processes transferred.


ESSENTIAL DUTIES AND RESPONSIBILITIES
  • Develop detailed understanding of the formulation and process to function as a subject mater expert (SME) in the generation and review of technology transfer documents.
  • Collaborate with formulation development and manufacturing teams to perform risk assessment and gap analysis of processes to be transferred.
  • Collaboration with project management for development of and adherence to project timelines.
  • Write and review batch records, protocols, and summary reports.
  • Problem solving and troubleshooting technology transfer issues.
  • Accurate documentation of procedures and results in real time during execution of engineering records and protocols.
  • Oversee execution of transfer batches in GMP manufacturing area.
EXPERIENCE AND EDUCATION REQUIREMENTS
  • BS or MS in pharmaceutics, engineering, or other related scientific discipline with 3 – 5 years of applicable experience in pharmaceutical manufacturing.
  • High school Diploma with 5 – 10 years of applicable experience in pharmaceutical manufacturing.
  • Experience in pharmaceutical product development or manufacturing is required.
  • Experience in a GMP manufacturing Environment is required.
  • Experience in writing GMP documentation is required.
  • Experience in manufacturing technology transfer is highly desired.
  • Good technical writing skills are required.
  • Must have strong communication skills
  • Must have experience with manufacturing processes such as: tableting, encapsulation, wet granulation, roller compaction, coating.
  • Working knowledge of manufacturing equipment or strong mechanical ability is required.
PHYSICAL DEMANDS/ WORK ENVIRONMENT
  • The Associate will spend time working in a GMP manufacturing environment and an office/desk setting with some time spent in a developmental laboratory as well.  Working in GMP manufacturing and developmental laboratory areas may include:
  • Working in gowning, appropriate for the potency of the compound(s) being processed, which may be restrictive to motion and comfort (e.g., Tyvek suit and hood with powered air purifying respirator (PAPR)).
  • Working around machinery at noise levels >70 decibels (with appropriate hearing protection available).
  • Working with potent to highly potent chemical compounds (using the appropriate PPE) with occupational exposure limits (OELs) as low as 0.03 µg/m3.

We are an equal opportunity/equal access/affirmative action employer fully committed to achieving a diverse workforce and complies with all applicable Federal and State laws, regulations, and executive orders regarding nondiscrimination and affirmative action with our hiring activities. We do not discriminate based on race, color, religion, ethnic or national origin, gender, genetic information, age, disability, sexual orientation, gender identity, gender expression, and veteran's status.

Notification to Agencies: Please note that CoreRx Inc. does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Master Service Agreement, and specific approval to submit resumes to an approved requisition, CoreRx Inc. will not consider or approve payment regarding recruiter fees or referral compensations.



Job Type: Full-Time

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