- Able to work independently with minimum supervision to develop formulations, manufacturing processes and associated test methods for different dosage forms, such as metered dose inhalers, nasal sprays, soft mist inhalers, and nebulized solutions and suspensions, and operate the various testing equipment and instrumentation used for characterization.
- Able to create/manage/execute method development and validation studies for product characterization.
- Able to create/manage/execute characterization and stability studies.
- Performing product performance and physical chemical characterization testing.
- Identifying and solving problems, recommend changes in the area of expertise.
- Analyzing data and writing reports, protocols, test methods, SOPs, and other documents.
- Provide technical support, and lead as requested, laboratory investigations, change controls, and CAPAs.
- Lead customer technical communication during customer calls.
- Represent the department in audits and customer visits, as required.
- Develop and conduct training for equipment/instrumentation, laboratory techniques, test methods, and protocols.
- Maintaining a safe work environment.
- May supervise a small team of junior chemists/scientists.
- Other duties as signed by management to meet company business needs.
- Lead laboratory investigations, change controls, and CAPAs.
- Represent the department in audits and customer visits, as required.
- Develop, approve, and/or conduct training for equipment/instrumentation, laboratory techniques, test methods, and protocols.
- Communicates project progress to project management and or sponsor. Escalates current and potential future equipment and resource constraints to management for resolution.
- B.S. degree in chemistry, pharmaceutical sciences, biological sciences, or related fields.
- Minimum of 4+ years of relevant lab experience.
- Thorough understanding of ICH, FDA, and other regulatory expectations for method validation, transfer and GMP testing
- A thorough understanding of general laboratory procedures to reliably conduct analyses and operate lab instrumentation.
- Strong oral and written communication skills for reporting experimental results.
- Self-motivated, and well organized with excellent time management abilities and problem-solving skills.
- Experience in working both independently and in a team-oriented, collaborative environment.
- Inhaled product testing (e.g. cascade impaction, delivered dose, spray characterization)
- Experience with equipment such as coulometric Karl Fischer, FT-IR, osmometer, HPLC, Gas Chromatograph.
- Experience with particle size analyzers and/or SprayVIEW Measurement Systems a strong plus.
- Experience with formulation & process development studies utilizing small scale equipment
- Experience in a contract lab organization
- Advanced Microsoft Word and Excel functions
- Creative thinking and problem solving skills
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Inhalation Scientist I/II - Morrisville, United States - Recipharm Laboratories
Description
Job Description
Job DescriptionSalary: DOERecipharm Laboratories officially became Bespak as of 4/1/2024.
Recruiters please do not contact this job poster. Please be advised: Bespak Laboratories does not accept unsolicited resumes or services from third-party recruitment agencies. In the event, a recruiter or agency submits a resume or candidate without an agreement we shall explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to Company employees, shall be deemed the property of the Company.
Bespak is a pharmaceutical Contract Development and Manufacturing Organization (CDMO) that offers development and manufacturing solutions for a variety of medications, including medical devices such as pressurized metered dose inhalers (pMDI), soft mist inhalers (SMI), dry powder inhalers (DPI), nasal sprays and medical check valves.
Our research and development facility in Research Triangle Park, NC, USA is seeking a Scientist to join us in our inhalation department. Our scientists and chemists work on a number of different projects for our clients which include small to mid-size pharma companies with focus on rare diseases to give patients with unmet medical needs better treatment options. This keeps us motivated and gives us the opportunity to make a difference and work on many different exciting, inhaled drug projects. This position is onsite only.
Key responsibilities will be:
Additional key responsibilities for level II will be:
Required Qualifications:
Preferred Qualifications:
Physical Requirements:
All Scientist positions must possess the ability to stand and/or walk for up to 8 hours a day and carry up to 25 pounds. This position involves repetitive motion of the arm, wrist, hand and fingers with the ability to feel and handle work materials for up to 8 hours per day. The position also requires the ability to carry out tasks involving extensive reaching, crouching, and bending. Day to day tasks may involve handling of and the ability to identify hazardous chemicals and materials.
We offer a competitive compensation and benefits package including:
Full Benefits (Medical, Dental, Vision, Life, Disability)
401(K) with Company Match
Paid Vacation, Sick Time, & Parental
Dependent Care FSA
Educational reimbursement program
**Relocation assistance is not provided for this position. Candidate must be able to commute daily to the job site**
COVID-19 considerations:
Vaccinations strongly recommended for all adults.
