Scientist - Raw Materials

Position Summary

The position is responsible for support of compendial testing group and manages priorities of this team to provide the timely, compliant and accurate testing of raw materials, critical utilities, in-process samples and finished product. This position will collaborate with cross-functional teams and will work side-by-side with other scientists and professionals to drive the scientific agenda. The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.

Essential Functions

• Performs routine/compendial testing utilizing a variety of techniques (e.g. wet chemistry, spectroscopy and chromatography).
• Performs protocol driven work in the testing of compendial materials.
• Assists with root cause identification, deviations, and corrective and preventive actions (CAPA).
• Effectively uses various laboratory software packages (Empower3, ProCal, Master Control, ELN, etc.)
• Identifies and follows improvement opportunities to enhance LEAN culture and infrastructure.
• Assists in removal of hazardous waste, routine equipment cleaning and restocking of consumable products and reagents.
• Works in tandem with a materials management team for effective sample transfer to/from sample storage and manufacturing facilities.
• Performs additional duties as required and assigned by management.

Education and Experience

• Bachelor's degree and 8 years of related experience required or Master's degree with 6 years of related experience required.
• Familiarity with using FTIR, cKF/KF, osmometer, Malvern, HIAC, HPLC/UPLC, GC, wet chemistry and other testing methods.
• Experience in a cGMP environment is preferred. Knowledge of USP, Ph.Eur., FDA, and ICH requirements as they apply to production and testing of drug substances and drug products is also preferred.

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

• Highly organized and detail oriented.
• Able to multitask in a fast-paced environment.
• Able to work independently, along with ability to work well within a team.
• Ability to communicate effectively, both orally and in writing.
• Ability to find a solution for or to deal proactively with work-related problems; ability to look beyond the standard solutions.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint) required.

Decision Making and Supervision Required

• Applies job skills and company policies and SOPs to complete a broad range of difficult tasks.
• Receives minimal instruction on day-to-day work, general instructions on new assignments.

Travel Requirements

• Up to 5% travel required.

Physical Demands and Work Environment

The physical demands and work environment 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, half face and full face respirator, 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.