Senior Scientist-Near Doylestown, PA
POSITION SUMMARY:
Leads, conducts, and oversees Analytical Research &Development, validation, optimization, and transfer of methods, API supplier and material qualification, drug product development, and aerosolization devices utilizing experience in assaying and characterizing drug product formulations (preferably peptides/lipids). Design and implement project plans and budgets. Provide oversight and technical subject matter expertise to outside testing laboratories and laboratory partners. Lead and/or actively participate in OOS/OOT, laboratory, complaint, and manufacturing investigations and method troubleshooting. Establish role as the subject matter expert for advanced analytical chemistry (including degradation pathway assessment and impurity identification) for current and development products. Performs all work in accordance with cGMPs and company’s standard operating procedures. Performs in-depth reviews (i.e., auditing) of laboratory notebooks and analytical records/reports. Represents ATS in project teams.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Responsibilities include, but are not limited to:
- Design, execute, and oversee analytical method development and validation in support of drug substance, drug product, device development, clinical studies, research studies, and product commercialization.
- Establish and maintain project plans and budgets in support of assigned commercial or product development activities.
- Maintain current on advanced analytical chemistry methods and techniques including: degradation pathway assessment and impurity identification, UV, ELSD, physical testing, CAD, LC/MS, and structural characterization.
- Design, conduct and oversee scientific experiments to resolve and/or optimize process/product related problems and investigations.
- Manage multiple and complex problems where the analysis of situations or data requires an in-depth evaluation of various factors is required.
- Prepare scientific and technical (data supported) investigation and research reports, method validation/transfer protocols and reports, SOPs, study protocols, and presentations.
- Coach, mentor, and train ATS Laboratory personnel as needed or required.
- Prepare and/or review regulatory submission documentation, as required.
- Performs routine testing as needed in accordance with cGMP and company’s standard operating procedures.
- Performs in-depth reviews (i.e., auditing) of laboratory notebooks and analytical records/reports.
- Represents ATS in project teams.
- Perform other duties and projects as assigned.
CUSTOMERS OR CLIENTS:
- ATS Laboratory personnel
- Senior Management
- Quality Assurance
- Research and Development
- Manufacturing Operations
- Outside Testing Laboratories
- Suppliers/Vendors
- Regulatory Affairs
EDUCATIONAL REQUIREMENTS (degree, license, certification):
Ph.D. degree in Chemistry, Biochemistry or related subject from an accredited college/university is required.
YEARS OF EXPERIENCE:
At least eight (8) years of pharmaceutical or biopharmaceutical industry experience in an analytical development or GMP release laboratory is required. Hands on drug product development experience performing progressively more responsible laboratory work and project management is desirable. A working experience with lipids, peptides, and/or liposomal structure and analysis is preferred, but not required.
PHYSICAL REQUIREMENTS / WORKING CONDITIONS of POSITION:
The employee must have the ability to work in a laboratory and may frequently be required to stand, walk, reach with hands and arms, stoop, kneel, or crouch, and talk or hear. The employee may be required to sit for long periods of time. The employee must be able to lift and/or move up to 25 pounds.
This position may require periodic domestic and international travel (approximately 5-10%).
OTHER SKILLS AND ABILITIES:
- Possesses a strong background in HPLC, LC/MS, and other analytical techniques.
- Working knowledge of aseptic processing of parenteral and/or aerosol delivery is preferred.
- Project Management with the demonstrated ability to establish and lead cross-functional teams is strongly preferred.
- Ability to educate stakeholders, customers and management.
- Ability to interface with internal customers, 3rd-party partners, supplier, and regulatory agencies.
- Strong negotiation, influencing, and conflict resolution skills.
- Excellent written and verbal communication skills including proficiency in the preparation of technical reports.
- In-depth knowledge of current GLPs, GMPs, USP/EP, and ICH Guidelines.
- Demonstrated ability to work well in a team environment is a must.
- Detail oriented.
- Proficient in Microsoft Office (Excel, Word, PowerPoint), and Access.
- Advanced math, algebra, statistical and experimental design skills.
- Working expertise with Waters chromatography software (preferably Empower) is required.
- Experience with Millennium and SLIM is a plus.
For immediate consideration, please send resume in Word Doc. to Lisa G. – Lisag@scientificsearch.com
.Net Web Developer-Near New Brunswick
FULL TIME DIRECT-NO CONTRACTORS, NO 3RD PARTY CALLS, NO SPONSORSHIPS
We have an immediate opportunity to fill a permanent position for an experienced .Net web developer. This position is responsible for producing and maintaining rich internet applications (RIA) for the auto industry and to work with a team in a deadline intensive environment. Responsibilities include: Gathering requirements; Site Analysis; Coding Custom WCF services, ASP.Net pages, SQL stored procedures and designing an object oriented system using .Net technologies and SQL Server. Web based development experience with jQuery, Microsoft Ajax and various JavaScript frameworks is required.
Candidates must possess senior level experience with ASP.Net, WCF, and SQL Server, C #/VB.Net, JavaScript and HTML skills. Candidates must also have very strong JQuery/Ajax skills, JavaScript templating and JavaScript frameworks experience and should not rely on a WYSIWYG editor. The position requires autonomous self-starters who can build complete features from end to end while keeping pace with an aggressive schedule. Development is done using Agile methodologies, so familiarity with Agile is a definite plus. The developer should work well with feature driven development rather than task driven development. A candidate for this position will need to be strong technically as well as having good problem solving and communication skills, along with the ability to quickly and effectively determine the best solutions. The candidate should also be able to solve for the problems inherent in building and delivering a high volume, high availability, high profile site with a focus on a consistent and easy to use interface. Experience with Visual Studio 2010/2012, .Net (ASP.Net, WCF, C# or VB) and SQL Server is required.
Responsibilities:
- Design and develop customer facing ASP.Net applications using C#, JavaScript, JQuery and Ajax. These applications are supported by WCF and SQL Server.
- Work closely with Product Management and backend development team to generate product specifications for new features
- Take features from concept to release through all phases of development: Functional and Design specifications, implementation and unit, performance and scalability testing.
- Work with remote team members on development and collaborate with QA to ensure quality of deliverables
Qualifications:
- Bachelors Degree
- 5+ years of experience as a developer (at least 3 years as a C#/VB.Net.Net developer)
- 3+ years SQL Server development (T-SQL)
- Experience with Agile development methodologies
- Hands on experience with implementation and performance tuning of enterprise applications
- ASP.Net, JQuery, Ajax, MVC, WCF, LINQ, T-SQL, .Net 2.0, 3.0, 3.5, 4.0, IIS 7.5+
- Working knowledge of Visual Studio and Team Foundation Server
- Strong JavaScript programming skills with deep understanding of AJAX frameworks
- Production UI design experience is a plus
- Experience developing web sites for mobile devices is a plus
- MSBuild and Powershell experience is a plus
- Thrive in a fast paced environment and meet stretch goals
- Strong time management and organizational skills
- Excellent verbal and written communication skills
- Ability to work in a remote team setting and independently
- Ability to understand and interpret existing site design and style guides to inform your work
- Thrive in a fast paced environment and meet stretch goals
- Strong time management and organizational skills
- Excellent verbal and written communication skills
- Ability to work in a remote team setting and independently
- Ability to understand and interpret existing site design and style guides to inform your work
