Job description

Overall Responsibilities:

Responsible for the timely execution of product development activities for pharmaceutical products. Responsible for the preparation of the complete development documentation required for the pharmaceutical product registration. Develops full ownership of technologies and best practices and serves as a model supporting technical activities. Provides technical support to manufacturing operations for marketed products in a contract manufacturing environment. Responsible for the execution and leadership of product and technology transfer activities ensuring timely completion and process robustness. Supports equipment qualification and cleaning validations efforts at the site. Develops and prepares protocols, reports, Manufacturing Batch Records, Standard Operating Procedures, and technical assessments. This position must comply with all security guidelines, Environmental Health and safety regulations and the current GMPs required for the job function.

Major Responsibilities:

1. Applies Quality-by-Design (QbD) principles to product development.

2. Performs literature/patent search for innovation product development and generic product development in supporting of regulatory submissions of NDA’s, and ANDA’s or patent filings.

3. Leads formulation development and manufacturing process definition for new solid dosage forms products.

4. Plans for and assume responsibility for development batches.

5. Reviews documentation related to formula and process to acquire the technical knowledge of products being manufactured and transferred (Pharmaceutical Data Sheet, comprehensive summaries, historical review, validation reports, NDA's, ANDA's and APR).

6. Evaluates the process for new or transferred products and, in conjunction with applicable groups, prepares pilot, full-scale or scale-up manufacturing instructions that can be validated that are efficient and suitable for stability studies.

7. Reviews analytical data, draft cGMP manufacturing batch records/protocols, and product development reports.

8. Writes formulation and manufacturing process development reports.

9. Collaborates with team members (analytical chemists, quality assurance and manufacturing technicians) to ensure assigned projects meet agreed timelines.

10. Performs other duties as may be required.

Minimum Requirements:

PhD/MS of BS Degree: Pharmaceutics, Chemistry, Chemical Engineering (or closely related scientific disciplines).

Chemist license preferred but not required.

Knowledge/Experience: Level

Product Development PhD/ms: 0-2 yrs.

BS: Min 2 yrs.

Design of Experiment Knowledgeable

Technical writing/oral communication skills (English/Spanish) Proficient

Computer literacy to include word processing & spreadsheet Software Proficient

Biopharmaceutical & pharmacokinetics principles Knowledgeable

Knowledge of Statistical Process Control & Process Capability Assessment Knowledgeable

Analytical & Problem Solving skills

Experience in Technical Transfer processes and requirements At least 2 yrs. of execution

(different types of formulations preferable)

Occasional travel may be required

Flexible to work in staggered shifts

Neolpharma Inc. is an Equal Employment Opportunity /Affirmative Action Employer committed to hiring a diverse and inclusive workforce. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. Neolpharma provides equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.

Neolpharma provides information to employees on the Federal laws prohibiting job discrimination based on race, color, sex, national origin, religion, age, equal pay, disability and genetic information. The EEO is the Law poster provides this information and may be accessed https://www.eeoc.gov/employers/eeo-law-poster. If you need an alternative format of the poster, you may request one by phone: (787) 286-4000.

Accessibility Accommodation

If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access www.neolpharmapr.com/Careerssite as a result of your disability. You can request a reasonable accommodation by calling (787) 286-4000 with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail or phone number. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to from this e-mail address and/or phone number.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in Puerto Rico to be fully vaccinated against COVID-19.

EEO Employer/Affirmative Action for Females/

Disabled/Veterans

Apply: http://www.neolpharmapr.com

If you meet the requirements, please apply in our web page – Thank You!

Job Types: Full-time, Temporary

Schedule:

• 8 hour shift
• Monday to Friday
• Weekend availability

COVID-19 considerations:
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in Puerto Rico to be fully vaccinated against COVID-19.

Ability to commute/relocate:

• Caguas, PR 00725: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Laboratory experience: 1 year (Preferred)

Work Location: One location

adamanda.ca is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, adamanda.ca provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, adamanda.ca is the ideal place to find your next job.