Assistant Scientist II - Microlab in North Charleston, SC at Apex Life Sciences

Date Posted: 10/2/2018

Job Snapshot

Job Description


Seeking a Microbiologist with 3-5+ years experience in a pharmaceutical manufacturing environment. This position is responsible for driving results in a very fast-paced environment. To be considered for this role, you must be proficient in performing complex microbial analysis, method development, and validation. This position also requires leadership. For immediate consideration, please send your updated resume to zburrell@apexlifesciences.com

Title: Assistant Scientist II – Micro Lab

Department: Quality Dept.

Job Family: Manufacturing Operations

About

This company 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 Assistant Scientist II is accountable for driving results in a fast-paced environment by performing more complex microbial analysis and assists in method development and validation. May assist in GMP review. The position requires superior leadership behaviors of the company’s 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 task.
  • Performs assigned tasks carefully and on schedule according to standard operating procedure and supervisors instructions.
  • 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.
  • Prepares technical write up and assist in report generation.
  • Accurately completes GMP reviews as assigned.
  • Maintains lab stock microbial cultures.
  • Interacts with clients.
  • Trains others on individual core technologies.
  • Reviews and revise procedures as requested and performance of advanced methods.
  • Participates in company training and maintain current status of certifications.
  • Complies with applicable GMP’s.
  • Provides technical training and leadership for subordinate technical positions.
  • Maintains a safe, clean, and organized work environment free from safety hazards.
  • Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

Education and Experience

  • Bachelor’s degree in related field with 3-5+ years of related experience. Chemistry, Biology, or Microbiology degree preferred. Course work in Microbiology expected.

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.

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.
  • Applicable GMP regulations.
  • General computer program operations inc., Word, Excel, Outlook.
  • SAP project status and CATS time entry functions.
  • NovaManage functions – look up and print documents, document editing and annotating.
  • Applicable lab standard operating procedures.
  • Moderate familiarity with classes of organisms.
  • Basic microbial taxonomy procedures.
  • In-depth understanding of microbiology test procedures including: preservative effectiveness, sterility testing, bacterial endotoxins, microbial limits, antimicrobial effectiveness, compendial regulation/ methods.
  • Basic theory of microbiology test procedures and validation.
  • Understanding of methods for environmental monitoring.
  • Proper documentation practices.
  • Execute procedures as written.
  • Recognize deviations from procedures and need for investigations.
  • Good aseptic techniques.
  • Independent use of more complex lab equipment.
  • Independently perform routine microbiological test procedures.
  • Perform more complex methods with supervision.
  • Perform method development and validation studies with supervision.
  • Assist in investigations.
  • Train less experienced analysts.
  • Perform environmental monitoring.

Supervisory Responsibilities

  • None

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.

Diversity and Inclusion

This company values diversity and we are committed 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, 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

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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