Full Time Science Policy Analyst Jobs in Raleigh, NC

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

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The Scientist - Formulations is accountable for driving results in a fast-paced environment and leading formulation development studies for the design and identification of safe, stable, robust and manufactural pharmaceutical dosage forms. The Scientist - Formulations independently designs, plans, performs, interprets and reports results of scientific experiments for the preparation and timely delivery of drug products (DP), processes and procedures needed for technology transfer and manufacture of the product. The position requires superior leadership behaviors as well as expertise in functional competencies including scientific principles, laboratory practices, cGMPs and regulatory requirements for pharmaceuticals and biologicals.

• 100% on-site position.
• 1st Shift: Monday - Friday, 8:00am - 5:00pm.

For Liquid and Sterile Formulation:

• Creates formulation development plans and executes well-designed experiments to define the qualitative and quantitative formulation composition.
• Conducts design of experiments (DoE) studies to identify and investigate key and critical quality attributes to confirm formulation robustness as per ICH Q8.
• Writes and executes protocols to prepare formulations for testing and characterization, methods development and technology transfer.
• Records and reports study results in compliance with good scientific policy and procedures.
• Evaluates new scientific technologies/equipment to enhance capability, capacity, and efficiency.
• Reports and presents scientific/technical results internally and to external clients.
• Utilizes complex tools/equipment, lab automation tools, and specialized facilities.
• Maintains and operates equipment according to safety standards and operating procedures.
• Reviews own work and conduct peer review.
• Participates in scientific conferences and contributes to scientific journals.
• Provides coaching and mentoring to junior colleagues and newcomers.
• Ensures timely completion and compliance with SOPs and all other relevant company training requirements.
• Other duties as assigned.

• Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or equivalent with 6-8 years of experience or Master’s degree with 2+ years of experience.
• Strong customer service focus and excellent customer contact skills.

• Thorough fundamental knowledge and understanding of solubility and stability theory and practice.
• A solid understanding of drug solubilization and stabilization techniques in liquid dosage forms.
• Hands on expertise in aseptic techniques for liquid formulation, compounding, and manufacturing.
• Experience in aseptic filtration, terminal sterilization and lyophilization process techniques.
• Knowledge of raw material selection strategy and criteria for parenteral and liquid dosage forms.
• Basic understanding of physical characterization tools such as DSC, particle size and different viscometers.
• Hands-on experience in analytical techniques such as UV-Vis and HPLC.
• Basic understanding of quality attributes and regulatory requirements for parenteral and liquid dosage forms.
• Basic understanding of quality attributes for biologics formulations.
• Knowledge of methods for characterization and testing of liquid and parenteral dosage forms.
• Ability to plan and manage multiple tasks for timely achievement of results.
• Ability to efficiently organize work with little or no supervision.

• Up to 5% travel required.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts and vibration. The noise level in the work environment is usually very quiet.

While performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. Other tasks involving elevated work may require the use of a body harness and lanyard. Additionally, the employee may be required to operate an industrial vehicle.