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Associate Scientist-Bioassay

Company: Alcami Corporation
Location: Wilmington
Posted on: January 16, 2020

Job Description:

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 Associate Scientist - Bioassay is accountable for driving results in a fast-paced environment with a focus on developing, validating and executing biological assays for biopharmaceutical products. A Associate Scientist-Bioassay will demonstrate proficiency in cell-based potency assays, ELISA, real-time PCR, enzymatic activity assays, binding kinetic assays and other biochemical testing methods. Problem-solving and troubleshooting skills along with proficiency in analyzing data, laboratory documentation, data presentation and collaboration are also desired. The position requires leadership behaviors of the Alcami core competencies and non-negotiables, as well as experience in functional competencies included in this position profile.



Essential Functions

* Supports troubleshooting and problem solving activities for cell-based and biochemical tests.

* Contributes to operational initiatives to support continued growth of the organization.

* Assists in Development and validation of biological tests to determine purity, identity and potency of pharmaceutical and biopharmaceutical products.

* Performs laboratory analysis of pharmaceutical and biopharmaceutical products utilizing analytical instrumentation, analyzes and documents data in accordance with Alcami SOPs.

* Documents results in electronic laboratory notebook.

* Writes test procedures, specifications and summary reports.

* Interacts with team members, management and clients to discuss data and project progress.

* Ensures timely completion and compliance with cGMP and all other relevant company training requirements.



Education and Experience

* Master s degree in Biology, Biochemistry, Chemistry or equivalent with 3+ years of relevant experience required.

* 2+ years of experience in Pharmaceutical, CDMO, or cGMP highly preferred.

* Demonstrated experience in developing analytical programs for one or more of the following products: peptides, monoclonal antibodies/recombinant proteins, cell therapy and gene therapy.



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

* Working knowledge of the biopharmaceutical industry is required.

* Working knowledge of peptides, monoclonal antibodies, recombinant proteins, cell therapy and gene therapy is required.

* Working knowledge of Cell-based Bioassays required.

* Working knowledge of Real-time PCR required.

* Working knowledge of ELISA/immunoassays required.

* Working knowledge of Enzymatic Activity Assays preferred.

* Working knowledge of Laboratory Documentation is preferred.

* Working knowledge of cGMP in a pharmaceutical or regulated environment is required.

* Excellent verbal communications and presentation skills required.

* Excellent time management and organization skills required.

* Excellent knowledge of Laboratory equipment and safety required.

* Good problem solving and trouble shooting ability required.

* Proficiency with Microsoft Office (Word, Excel, PowerPoint) required.





Travel Requirements

* Up to 5% Travel Required.



What We Offer You:

* Competitive salary with career advancement opportunities

* Profit sharing 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 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.
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Keywords: Alcami Corporation, Wilmington , Associate Scientist-Bioassay, Other , Wilmington, North Carolina

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