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Associate Scientist - Technical Writer

Company: Alcami Corporation
Location: Wilmington
Posted on: February 13, 2019

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



Seeking Scientist with excellent written and oral communication skills. Extensive experience in leading and authoring deviations and laboratory investigation required for consideration. Must demonstrate knowledge in use of root cause analysis tools and effective CAPA.

The Associate Scientist - Technical Writer is accountable for driving results in a fast-paced environment by providing project/study and investigation support through review, technical writing, and report generation for laboratory studies, investigation, and deviations. Assignments are of general complexity, where judgment and initiative are required to resolve problems and make recommendations. The Associate Scientist - Technical Writer must have a laboratory background and understanding of theoretical basis of laboratory methods and experiments. They will work on problems in which analysis of situations and information requires evaluation of various factors. They must maintain a high level of professional expertise through the familiarity of current ICH/FDA guidance and scientific literature and demonstrate a working knowledge of scientific principles. The Associate Scientist - Technical Writer must provide mentoring, training and general guidance and instruction to less experienced staff. They will work independently of instruction on diverse and complex work including new assignments requiring some general instruction. The Associate Scientist - Technical Writer is expected to interact with clients and to participate in FDA and/or client related meetings or audits. The Associate Scientist - Technical Writer will review research and development documents/data ensuring that the studies and information provided are scientifically sound and that investigations performed have been adequately documented and root cause determined. The position requires leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.

Essential Functions

* Authors and reviews investigations and CAPAs with minimal guidance.

* Generates basic study protocols under minimal guidance of laboratory leadership.

* Participates in gap assessments of technical documentation to ensure methods are installed up to current standards, and that processes investigated are present and functioning optimally. Provide recommendations/solutions to remediate any recognized gaps.

* Generates various types of client reports, including but not limited to: laboratory investigation, deviation, stability trend, method validation, and method transfer/verification reports.

* Generates various types of client protocols, including but not limited to: stability, standard qualification/characterization/crossover, method verification, validation, and transfer.

* Performs second check of data to ensure compliance with testing, product specifications, and/or protocol acceptance criteria.

* Resolves moderately complex questions and refers more complex questions to higher levels.

* Works with internal groups to initiate, write, and then to ensure the approval of test procedures, as needed, for project timelines.

* Organizes data into clear and concise professional presentations.

* Maintains consistent, accurate, and up-to-date notes and files.

* Effectively performs duties, on schedule, with accuracy and competency.

* Generates and revises SOPs, as needed.

* Assists in training other staff within the same job function.

* Interacts directly with clients individually or in groups to address general requests, obtain timelines for deliverables and provide status updates.

* May interacts with FDA to address any potential audit requests or observations

* Participates in company sponsored training, as needed.

* Maintains an organized data base/library for technical documents where documents are consistent in format and content.

* Provides feedback on processes for laboratory and quality improvements.

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



Education and Experience

* Bachelor s degree in Chemistry, Biology, or related science with 6+ years relevant experience required or Master s degree with 4+ years of technical writing documents for a CMC laboratory or GMP quality unit.



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. Step outside your comfort zone.

* 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

* Exercises judgment within defined procedures and practices to determine appropriate action.

* Excellent verbal communication, written communications, and presentation skills required.

* Excellent detail orientation and organizational skills required.

* Excellent problem-solving and basic trouble-shooting ability required.

* Excellent knowledge of ICH and compendial guidelines.

* Proven skills in technical writing of moderate complexity.

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

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

* Excels at collaborating in team settings.



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

Keywords: Alcami Corporation, Wilmington , Associate Scientist - Technical Writer, IT / Software / Systems , Wilmington, North Carolina

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