Formulation Scientist- Sterile Fill

The Scientist, Formulations is responsible for developing sterile parenteral, lyophilized products, and liposomal delivery systems.

Position Summary

The Scientist - Formulations is accountable for driving results in a fast-paced environment at our parenteral site in Charleston, SC, leading pre-formulation laboratory activities for early stage formulation development of liquid drug products for new chemical entities or new dosage forms for existing drugs. The Scientist - Formulations is instrumental in developing solutions, lyophilized injectables, sterile parenteral oral liquids, and liposomal delivery systems. The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies including scientific principles, laboratory practices, cGMPs and regulatory requirements for pharmaceuticals and biologicals. Knowledge of early phase drug development and the use of relevant physicochemical properties for solutions development preferred.

Essential Functions

• Performs laboratory work related to early stage formulation development of liquid drug products for new chemical entities or new dosage forms for existing drugs.
• Develops solutions, lyophilized and injectables, sterile parenterals and oral liquids, lyophilized products and liposomal delivery systems.
• Assists in implementing new methods/processes to solve problems.
• Writes standard operating procedures (SOPs), test procedures, specifications and summary reports.
• Documents results in electronic laboratory notebook.
• Maintains working knowledge of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks.
• Operates equipment in accordance with standard procedures.
• Writes client communications, deviations, specifications and investigations.
• Reviews own work and conducts peer review.
• Interacts with clients and participate in regulatory agency and/or client audits.
• May participate in scientific conferences and contribute to scientific journals.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• May train and supervise activities of less experienced scientists.

Education and Experience

• Bachelor’s degree in Pharmaceutical Sciences, Chemistry or equivalent with 5-8 years of experience or Master’s degree with 3 years of experience or Ph.D. with 2 years of experience required.
• Experience in development of parenterals and scale up or process development required.

Alcami Non-Negotiables

• Consistently demonstrates honesty and integrity through personal example.
• Follows all safety policies and leads by example a safety first culture.
• Produces high quality work product with a focus on first time right.
• Complies with the company code of conduct and policies and regulatory standards.

Alcami Core Leadership Competencies

• Thinks strategically. Quickly identifies and acts on opportunities. Considers the downstream impact. Seeks to understand the why. Focuses on work that matters.
• Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.
• Acts decisively. Makes and acts on decisions quickly. Makes decisions with the customer and their patients in mind. Meets commitments with a sense of urgency. Seeks ways to be more efficient.
• Drives performance. Holds self and others accountable. Delivers results first time right. Never settles for status quo. Willing to have tough conversations. Asks for feedback and takes action to improve.
• Passion for customers. Listens to understand. Asks the right questions. Gets to the heart of the matter and uses that insight to provide value.
• Works collaboratively. Seeks out the experience of others with the aim for better results. Open minded regardless where ideas originate. Flexible and easy to work with.

Functional Competencies

• Knowledge of cGMPs and regulatory requirements for pharmaceuticals and biologicals, scientific principles, laboratory practices and equipment, chemistry and scientific calculations required.
• Knowledge of early phase drug development and the use of relevant physicochemical properties for solutions development preferred.
• Experience developing parenterals and scale up or process development required.
• Excellent critical thinking and problem solving skills required.
• Excellent verbal and written communication skills required.
• Ability to develop and implement new methods/processes required.
• Ability to plan and manage multiple tasks for timely achievement of results.
• Ability to efficiently organize work with little or no supervision.

Decision Making and Supervision Required

• Uses professional concepts and company policies and SOPs to solve a broad range of difficult problems.
• Independently determines methods and procedures, including assignments and the work of others.

Travel Requirements

• Up to 5% travel required.

Physical Demands and Work Environment

The physical demands and work environment characteristics 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 stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is occasionally required to walk; sit; climb or balance 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 wet and/or humid conditions; moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; 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, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Job Type: Full-time

Pay: $68,000.00 - $105,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Referral program
• Relocation assistance
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday
• Overtime
• Weekend availability

Supplemental Pay:

• Bonus pay

Education:

• Bachelor's (Required)

Experience:

• pharmaceutical lab: 6 years (Required)
• Sterile Fill Formulations: 2 years (Preferred)

Work Location: One location