Position Summary

The Associate Scientist I is accountable for driving results in a fast-paced environment by performing complex microbial analysis and assisting with method development and validation. The Associate Scientist I may assist in GMP review, provide problem solving support and Laboratory Investigation Report ownership for the Microbiology Department. 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

• Maintains working knowledge of instrumentation, equipment and scientific methodologies necessary to perform assigned tasks.
• Isolates and makes cultures of bacteria or other microorganisms in prescribed media, controlling moisture, aeration, temperature and nutrition.
• Examines physiological, morphological and cultural characteristics, using microscope and other relevant equipment, to identify and classify microorganisms in test articles.
• Manage the incubation of samples, plate reading and reporting of results. Accurately completes GMP reviews as assigned.
• Maintains lab stock of microbial cultures.
• Interacts with clients.
• Reviews and revises procedures as requested.
• Participates in company training and maintains current status of certifications.
• Provides technical training and leadership for support level technicians.
• Assist in sustaining of the laboratory safety and cleanliness by maintaining inventory, disposal of waste and routine cleaning of laboratory rooms and equipment.
• Ensure required testing documentation is complete and generated with adherence to company policies and procedures.
• Support development of LIMS templates.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Perform sampling of air for viable and non-viable particle counts along with contact surface testing.
• Perform sampling and testing of facility gasses and water including pre-treatment, USP and Water for Injection.
• Escalate to management any failures and concerns related to environment of controlled spaces.
• Assist in receipt and log in of in-process samples.

Education and Experience

• Bachelor’s degree in Microbiology or similar field and no 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

• Knowledge of Chemistry and Biology plus course work in Microbiology.
• Basic and moderately complex mathematical functions.
• Familiar with GMP regulations.
• General working knowledge of Microsoft Office applications.
• SAP project status and CATS time entry functions.
• Moderate familiarity with classes of organisms.
• Basic knowledge of microbial taxonomy procedures.
• Understanding of basic theory of Microbiology test procedures and validation.
• Understanding of methods for environmental monitoring.
• Good documentation practices.
• Able to execute procedures as written.
• Ability to recognize deviations from procedures and need for investigations.
• Good aseptic techniques.
• Able to independently use more complex lab equipment.
• Ability to independently perform routine microbiological test procedures.
• Able to perform more complex methods with supervision.
• Assist in investigations.
• Able to train less experienced analysts.
• Ability to perform environmental monitoring.

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 use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to stand. The employee is occasionally required to walk; sit 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 frequently exposed to moving mechanical parts and risk of electrical shock, burn hazards and microbial contamination. The employee is occasionally exposed to fumes or airborne particles; toxic or caustic chemicals 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.