Think Different. Do Different. Be Different.
Alcami is a world-class contract development and manufacturing organization (CDMO). We are a team of dynamic individuals committed to developing life-saving drugs 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.Position Summary
The Scientist, Microbiology 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 routinely lead method suitability/method validation projects. Bacterial endotoxins, sterility, microbial examination and antimicrobial effectiveness based methodologies are commonly employed in the described 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.Essential Functions
Education And Experience
- Combination of basic and advanced skills in multiple techniques, to include: use of proper aseptic technique, operation of microscope, pH measurement, isolation of pure cultures and strong pipetting skills.
- Current knowledge in industry standards and regulatory requirements as applicable to microbiology.
- Represents microbiology department during client and regulatory visits.
- Achieves results by solving problems of a diverse scope.
- Drives initiatives outside of standard work function.
- Evaluates and interprets data.
- Analyzes information for technical correctness and accuracy.
- Understands the theoretical basis of methods/experiments.
- Writes methods, test procedures, protocols and reports.
- Executes method suitability/validation and routine testing with little to no assistance.
- Maintains working knowledge of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks.
- Maintains a safe, clean, and organized work environment free of safety hazards.
- Safely handles potent compounds.
- Leads investigations and root cause analysis.
- Examines physiological, morphological and cultural characteristics, using microscope and other relevant equipment, to identify and classify microoganisims in test articles.
- Studies impact of microorganisms on products and evaluate impact of microbial control strategies on microorganism survival.
- Prepares technical write up and assist in report generation. Offer conclusions and recommendations based upon study outcomes.
- Interacts with clients. Supports client projects to include client calls, technical expertise and recommendation of test plan.
- Performs method development and validation independently.
- Participates in process improvements.
- Provides technical training and leadership.
- Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
- Bachelor's degree in Microbiology, Biology or equivalent with 8-10 years of experience or a Master's degree with 5-7 years of experience required.
- 2+ years of experience in Pharmaceutical, CDMO, or cGMP preferred.
Alcami Core Leadership Competencies
- 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.
- 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.
Decision Making And Supervision Required
- 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.
- Working knowledge of cGMP in a pharmaceutical or regulated environment preferred.
- Proficiency with Microsoft Office (Word, Excel, PowerPoint) 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.
Physical Demands and Work Environment
- Up to 5% travel required.
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. What We Offer You:
Diversity and Inclusion:
- 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
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. As part of our effort to provide and maintain a safe and healthful workplace, Alcami Corporation requires new hires to be fully vaccinated against COVID-19. Individuals are considered fully vaccinated 2 weeks after their second dose of the Pfizer or Moderna vaccine, or 2 weeks after a single-dose of the Johnson & Johnson vaccine. Individuals seeking an exemption from this requirement for medical or religious reasons should contact HR to complete a request for accommodation form.