Alcami is a world-class contract development and manufacturing organization (CDMO). We are a team of dynamic individuals committed to developing life-saving and life-changing drug products around the world. A mindset of innovation, accountability and customer focus inspires us to be the most efficient, safe and reliable choice for our customers and the patients they serve. In return, we offer challenging careers, accelerated professional growth and the opportunity to be part of something different.
A Scientist is accountable for driving results in a fast-paced environment by performing microbiological routine and non-routine testing in support of pharmaceutical product development or pharmaceutical manufacturing and stability. A Scientist will rountinely lead method suitability/method validation projects. Bacterial endotoxins, sterility, microbial examination and antimicrobial effectiveness based methodologies are commonly employed in the described testing. Other key methodologies applied include: liquid particulate matter and genetic identification testing. Test methods employed may be compendial (i.e. USP, EP) or proprietary (client supplied or developed by The Company). 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.
* Combination of basic and advanced skills in multiple techniques, to include: use of proper aseptic technique, operation of microscope, Gram staining, pH measurement, isolation of pure cultures, understanding of rapid techniques and strong pipetting skills.
* Isolates and makes cultures of bacteria or other microorganisms in prescribed media, controlling moisture, aeration, temperature and nutrition.
* Performs tests on water, test articles and the environment to detect harmful microorganisms and to obtain information on types and levels of microbial contamination.
* Examines physiological, morphological and cultural characteristics, using microscope and other relevant equipment, to identify and classify microorganisms in test articles.
* Studies impact of microorganisms on products and evaluate impact of microbial control strategies on microorganism survival.
* Achieves results by solving problems of a diverse scope.
* Drives initiatives outside of standard work function.
* Writes methods, test procedures, protocols and reports.
* Executes method suitability/validation and routine testing with little to no assistance.
* Maintains working knowledge of routine instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks.
* Performs assigned tasks carefully and on schedule according to standard operating procedure and supervisor instructions.
* Analyzes information for technical correctness and accuracy.
* Complies with applicable GMPs, peer checks information and signs for GMP review. Brings aberrant information to the attention of supervisor.
* Participates in company sponsored training and maintains current status of certifications.
* Maintains a safe, clean, and organized work environment free of safety hazards.
* 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 Chemistry, Biology, Microbiology or a related field with course work in Microbiology with 5 - 7 years industry experience or a Master's degree with 3 - 5 years of experience required.
* Prior laboratory experience or work experience in Pharmaceutical, CDMO, or cGMP preferred.
* 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.
* Knowledge of Chemistry and Biology plus course work in Microbiology.
* Basic mathematical functions.
* Strong familiarity with major classes of microorganisms.
* Working knowledge of applicable GMP regulations.
* General computer program operations, inc. Word, Excel, Outlook.
* Advanced theory of microbiology test procedures.
* General working knowledge of ERP project status and time entry functions.
* Working knowledge of applicable lab standard operating procedures.
* Able to perform routine microbiological test procedures without supervision.
* Proper documentation practices.
* Use of basic lab equipment and some more complex equipment with minimal assistance.
* Execute procedures as written.
* Ability to recognize deviations from procedures and need for investigations.
* Excellent aseptic technique.
Decision Making And Supervision Required
* Applies job skills, company policies and SOPs to complete a variety of tasks.
* Receives general instructions on routine work, detailed instructions on new projects or assignments.
* 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.
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.
What We Offer You:
* Competitive salary with career advancement opportunities
* Bonus plan
* Medical, dental and vision coverage from day one
* 401(k) with company match
* Company paid vacation, holiday and sick-leave
* Voluntary benefits including short & long-term disability, life, accident, critical illness insurances
Diversity and Inclusion:
Alcami values diversity and we are c ommitted to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, sexual orientation, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.