Inhalation & Formulation Chemist I/II

We are seeking a Chemist I / II to join our Inhalation Formulation Development (IFD) Department here at Recipharm RTP. The level of the position will be based on qualifications and experience.

 

This position has a minimum 80% expectation of hands on, in the lab testing. Key responsibilities will be:

• Executes test methods and sections of protocols for product characterization.
• Processes & documents results in a timely manner, escalating OOS/OOT results to project Technical Leader (TL) and management for immediate action.
• Ensures department compliance with laboratory maintenance & cleaning, safety procedures and OSHA requirements for material handling.
• Execute method validation, method transfers, and compendial verifications for inhalation drug product characterization.
• Hands on instrumentation, method techniques, and software use (i.e. Cascade Impaction, Spray Characterization including Droplet Size Distribution by Laser Diffraction, Spray Content Uniformity, Osmolality, Foreign Particulate Matter).
• Participate in and author sections of deviations, laboratory investigations, invalid data events, root cause analyses, change controls, CAPAs, and other Quality System procedures as required.
• Ensures department compliance with laboratory maintenance & cleaning, safety procedures and OSHA requirements for material handling.
• Represents the department in audits and customer visits.
• All IFD Chemist positions may be required to perform other duties as required by management to meet company business needs.

 

Required Qualifications:

 

The Chemist I position requires an AS degree in Chemistry (or related Life Science) and 4+ years of relevant life science industry experience, a BS degree with 2+ years of relevant life science industry experience, or an MS with no experience required.

The Chemist II position requires an AS degree in Chemistry (or related Life Science) and 6+ years of relevant life science industry experience, a BS degree with 4+ years of relevant life science industry experience, or an MS with 1+ years of relevant life science industry experience.

 

• Thorough understanding of general laboratory procedures to reliably conduct analyses and operate lab instrumentation.
• Understanding of ICH, FDA, and other regulatory expectations for method validation, transfer and GMP testing.

 

Preferred Qualifications

 

• Experience with inhaled dosage forms and devices used for inhalation drug delivery.
• Experience with formulation & process development studies utilizing small scale metered dose inhaler filling equipment, dry powder blending and filling equipment, and/or liquid formulation for soft mist inhaler and nebulizer solutions.
• Understanding and experience with 21 CFR Part 11 requirements for electronic records/signatures, data management, and industry requirements for data integrity.

Physical Requirements

All Chemist 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

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:
Per local mandate, masks are required on site. Vaccinations strongly recommended for all adults.

Company Description:
Recipharm is a leading CDMO (contract development and manufacturing organization) in the pharmaceutical industry employing 9,000 employees with headquarters in Sweden. One of Recipharm’s nine research and development facilities is in Research Triangle Park, North Carolina, USA. Recipharm Laboratories aspires to be the first-choice strategic partner for inhaled drug development companies worldwide.