Position Summary

The Senior Scientist, Formulations is accountable for driving results in a fast-paced environment by supporting pre-formulation laboratory activities for early stage Formulation development of sterile liquid and lyophilized drug products with new chemical entities, or new dosage forms for existing drugs. The Senior Scientist will develop sterile parenterals, lyophilized products, and liposomal delivery systems. The role will contribute to the solving of complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. This role will be a subject matter expert in Steriles Formulation Development, ensuring clients have the best development solutions for their products. The ideal candidate will also work with Business Development and Project Management with budgeting, establishing project timelines and making technical recommendations to customers. This role will be expected to stay abreast of the latest technology and how it may be used to keep Alcami at the top of the industry. The Senior Scientist will exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. The Senior Scientist will determine methods and procedures on new assignments and may provide guidance, mentoring and training to other personnel. 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 activities related to the development of sterile formulations for liquid, suspension, LNP and lyophilized dosage forms
• Manufactures small-scale prototype and stability batches to enable lead candidate selection and toxicology studies in non-GMP and GLP environment
• Utilizes technologies such as TFF, TS and lyo cycle development to create formulations suitable for vial or PFS drug delivery systems
• Generates comprehensive development protocols and reports for customers
• Demonstrates working knowledge of scientific principles.
• Prepares summaries of observations, capable of verbal and written presentations to peers.
• Maintains a high level of professional expertise through familiarity with scientific literature.
• Interacts with clients and may participate in FDA and/or client audits.
• Writes SOPs, training modules, specifications and summary reports.
• Assists in implementation of new methods/processes to solve problems.
• Updates all stability tables and maintains organized product records.
• Maintains working knowledge of instrumentation, equipment and scientific methodologies necessary to perform assigned tasks.
• Maintains basic understanding of underlying scientific principles.
• Analyzes information for technical correctness and accuracy.
• Complies with GLPs and SOPs and transcribes data and information accurately. Peer checks information and signs for GLP review. Brings aberrant information to the attention of supervisor and executes minor QA deviations per standard operating procedures.
• Participates in company sponsored training and maintains current status of certifications.
• Maintains a safe, clean and organized work environment free of safety hazards.
• Enters project hours promptly and updates project status on appropriate tracking and/or timekeeping systems.
• Suggests improvements for safety, work quality and productivity.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

Education and Experience

• Bachelor's degree in a related field with a minimum of 12 years of experience required or a Master's degree in a related field with a minimum of 8 years of related experience 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

• Extensive knowledge of Chemistry and scientific calculations.
• Extensive Laboratory Skills (equipment usage, terminology, etc).
• General working knowledge of Microsoft Office software, including Word and Excel.
• General working knowledge of Lab Techniques (i.e. extractions).
• Good understanding of GLP/GMP Policies/Regulations.
• General working knowledge of Spectroscopy (i.e. UV, IR, AA), Titronics (i.e. KF).
• Ability to efficiently organize routine work with minimum supervision and to properly evaluate and interpret generated data is required.
• Ability to work well in a team setting and to collaborate across working groups.
• Ability to plan and schedule multiple tasks.
• Ability to work with potent compounds and controlled substances as well as meet timelines.

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 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.