Sr. Scientist Bioseparations/Mass Spec

Position Summary

A Senior Scientist is accountable for driving results in a fast-paced environment by performing analytical routine and non-routine testing in support of pharmaceutical product development or pharmaceutical manufacturing. A Sr. Scientist will routinely lead method development/method validation projects. HPLC, dissolution and/or GC based methodologies are commonly employed in the described testing. Other key methodologies applied include: mass spectrometry, electrophoresis, titrations, UV, AA, IR. Test methods employed may be compendial (i.e. USP, EP) or proprietary (client supplied or developed by The Company). Detailed understanding of the theoretical basis of the methods/experiments along with ability to troubleshoot equipment are also required. The incumbent will work on extremely complex problems in which analysis of situations or data requires an evaluation of tangible and intangible variables. 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

• Uses advanced skills in multiple techniques, to include: assays (potencies, related substances), dissolution/drug release, residual solvents, elemental impurities, moisture content, identification and various other wet chemistry based measurements.
• Develops and validates methods, test procedures, protocols and reports.
• Understands the theoretical basis of methods/experiments.
• Maintains strong knowledge of instrumentation, equipment and scientific methodologies necessary to perform assigned tasks.
• Analyzes information for technical correctness and accuracy.
• Evaluates and interprets data.
• Achieves results by solving problems of a diverse scope.
• Interacts with clients and participates in regulatory agency and/or client audits.
• Leads investigations and root cause analysis.
• Drives initiatives outside of standard work function.
• Maintains a safe, clean and organized work environment free of safety hazards.
• Safely handles potent compounds.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

Education and Experience

• Bachelor's degree in Chemistry with 12 years of experience or Master's degree with 8 years of experience, or Ph.D. with 5 years of experience required.
• 5 years of experience in Pharmaceuticals drug product development under cGMP is required.
• CDMO experience is 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

• Excellent verbal and written communication and documentation skills required.
• Excellent detail orientation and organizational skills required.
• Excellent problem-solving and basic trouble-shooting ability required.
• Excellent knowledge of laboratory equipment and safety required.
• Expert knowledge of Laboratory Documentation is required.
• Ability to develop and implement new methods/processes required.
• Ability to plan and manage multiple tasks for timely achievement of results.
• Working knowledge of cGMP in a pharmaceutical or regulated environment required.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint) required.

Decision Making and Supervision Required

• Uses professional concepts and company policies and SOPs to solve a variety of problems.
• 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 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.