North Jersey Section 0304 Empoyment Trends Archives

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5/20/11
Lead Technician – Facilities, Biotech, New Jersey
The responsibilities include operation, maintenance and repair of the Facility’s DIW and WFI water systems, Clean Steam Generator and Distribution systems, Boilers, Chillers, Cooling Towers and Glycol Distribution, Compressed Air, UPS, Emergency Generator, Electrical Distribution, BMS, Process Gas, Heating/Hot Water, Natural Gas Booster Skid, Industrial and Biowaste systems.

Preventative maintenance on the Utilities mechanical systems, with working knowledge electrical, plumbing and rigging. Assist with new equipment installation, as well as other assigned duties.

1. Operate and troubleshoot all problems as they occur on Plant Steam Boilers, Chillers, Cooling Towers, Emergency Generators, Process Gas Equipment, and Water for Injection, DIW Pretreatment and Generation, Compressed Air, Bio Waste and Industrial Waste, Clean Steam, Heating Hot Water Skids, and other equipment in the Utility Room as required. In order to accomplish this, the individual must be fully knowledgeable and understand all aspects of equipment operation and maintenance.
2. Maintain full knowledge of the BMS System as required for operating equipment and troubleshooting issues as they relate to equipment and the buildings Utility Systems.
3. Perform all assigned PM’s and WO’s on facilities equipment as per predetermined schedule and Sop’s. Document all work as performed according to cGMP’s and company SOP’s. Document the use of spare parts in all PM and corrective maintenance WO’s. Provide assistance as required regarding the use and need of spare parts.
4. Provide ongoing insight to Supervisors, Specialists, and Managers where SOP’s and PM Job Plans are to be updated based on current operations.
5. Maintain cleanliness of the Utility Room, chiller yard and equipment.
6. Maintain 100% training records in ELM for all required training.
7. Analyze and maintain proper water chemistry on the Boilers, Cooling Towers and DIW systems.
8. Perform all aspects of the position by following cGMP’s and all Safety and OSHA regulations.
9. Provide 24 hour emergency response and shift coverage as needed.
10. Manage outside contractors and ensure contractors are properly trained and the training is documented before any work is performed.

Monitors overall job environmental, health and safety aspects and understands the risks and liabilities associated with various facilities maintenance and repair activities.
Must be able to recognize hazard conditions, take appropriate work place safety measures and wear appropriate personal protective equipment to suit work environment.

Required Knowledge, Skills & Education:

1. This position is required to operate, trouble shoot and service all problems as they occur on the Plant Steam Boilers, Chillers, Cooling Towers, Emergency Generators, Process Gas Equipment, Water for Injection, DIW Pretreatment and Generation, Compressed Air, Bio Waste and Industrial Waste, Clean Steam, Heating Hot Water Skids, and all other equipment in the Utility Room as required.
2. Work performed must be in compliance with the Facility Maintenance Program. cGMP’s, Safety, and OSHA requirements.
3. Provide electrical and plumbing services for new installations as required.
4. This position supports Manufacturing, Facilities and Utilities, located within BB50.
5. This position is accountable for the coverage needed to support 24 hour emergency response.
6. Minimum High School Diploma or equivalent. Associates degree in a technical field is preferred.
7. Must possess at a minimum a High Pressure Black Seal New Jersey State Operator’s License.

Work Shift:
Rotating 12 hour shifts
4 days on (6:00am-6:00pm), 4 days off, 4 nights on (6:00pm-6:00am), 4 nights off on a continuous rotation

Manager – Regulatory CMC, Biotech, New Jersey
The Manager, CMC Regulatory Affairs will develop global regulatory CMC strategy and submissions for assigned biologic development projects and/or marketed products in conjunction with appropriate RA CMC management. This includes planning, review, coordination and submission of IMPDs, CTAs, INDs, BLAs, etc.

The candidate will proactively provide strategic input and communicate critical topics in a timely manner to interdisciplinary project teams and appropriate management level. Lead cross functional Health Authority response teams for assigned development projects to set objectives for HA meetings, manage interactions and coordinate preparation of HA responses. The candidate must have competent knowledge of current / emerging regulations, guidance documents and corporate/industry standards. Must be detail-oriented with good oral and written communications skills; able to prepare accurate, clear and concise regulatory documents and manage the quality review process. Excellent time management skills essential; must be able to multi-task and drive timelines for deliverables.

Primary Responsibilities:

1. Will have understanding of regulatory CMC requirements, FDA, EMEA, ICH guidelines and relevant government regulations (21 CFR, EU Directive).
2. Provides regulatory guidance to ensure development activities are compliant with relevant health authority regulations and in line with current global guidance.
3. Communicates global regulatory strategy and guides manufacturing in developing data for approval of post-marketing changes.
4. Represents Regulatory CMC on interdisciplinary teams and technical project teams to outline submission requirements and negotiate timelines for delivery of regulatory CMC submissions.
5. Assists in preparation of risk analyses and contingency plans for CMC regulatory strategies and dossiers.
6. In conjuction with multi-disciplinary teams, prepares the CMC section of INDs, BLAs, CTAs, CTDs, amendments, supplements and annual reports, including the compilation and review of the required data, scientific reports, and written submission contributions.
7. Reviews and assesses the regulatory impact of change controls/requests for the manufacture, testing and release of development and marketed products.
8. Assists in the implementation of processes and applications to support regulatory activities

Required Skills, Knowledge, & Education:

1. Must have 3 – 5 years of pharmaceutical industry experience including a minimum of 2 years of regulatory or related experience.
2. Demonstrated knowledge of the drug/biologics development process and government regulations/guidelines, including US and international product registration.
3. Good oral and written communication skills with a focus on accuracy (vigilant attention to detail) and clarity are essential.
4. BA/BS degree or equivalent experience.

Principal Research Associate, Biotech, New Jersey
Perform complex analyses by appropriate protein characterization methods, develop new assays, and conduct test method qualification/validation. Apply acceptable cGMP practices during execution of all applicable work tasks. Work independently with limited supervisory guidance.

Primary Responsibilities:

• Perform complex analyses of test articles by appropriate protein characterization methods.
• Research new methods. Develop new assays. Compile/analyze data. Write SOPs.
• Write validation protocols/reports. Coordinate and conduct tech transfer to other groups/sites.
• Conduct test method qualification/validation following pre-defined protocols for new assays, as needed.
• Demonstrate initiative to assure performance of all routine and non-routine responsibilities.
• Apply acceptable cGMP practices during execution of applicable work tasks.
• Exhibit strong teamwork and communication skills. Collaborate with other departments as needed.
• Work independently with limited supervisory guidance.
• Update Management of progress. Seek additional guidance as needed.

Required Knowledge, Skills & Education:
• B.S. or M.S. in a related science such as Protein Chemistry, Biochemistry or Biology.
• Requires 5+ years for BS and 3+ years for MS of previous related experience in methods validation, protein chemistry, tech transfer and applied scientific expertise.
• Must have protein handling experience.
• Experience in glycan characterization is preferred.
• Experience in protein mass spectrometry is a plus.
• Excellent working knowledge of cGMP regulations is required.
• Excellent teamwork and communication skills. Attentive to detail. Good computer skills.
• Ability to work independently, to achieve problem resolution, to troubleshoot and develop/validate assays with limited supervision.

Senior Research Associate, Biotech, New York City
The primary responsibility of the Bioanalytical Scientist is to develop and qualify immunological-based quantitative assays for novel monoclonal antibody therapeutics and pharmacodynamic markers in support of nonclinical studies. To that end, the incumbent must be able to troubleshoot assays and effectively compile and present scientific data to the members of the department. In many cases these assays will be transferred to external contract research organizations (CROs) for implementation in large scale GLP studies. The incumbent will participate in the transfer of qualified assays to CROs through the preparation of qualification reports and experimental protocols. In addition to assay development and qualification, the incumbent will be responsible for performing sample analysis and preparing the associated bioanalytical reports. All aspects of sample analysis, including non-linear regression analysis, sample tracking, and report generation are managed through the WatsonTM laboratory information management system (LIMS). The incumbent will serve as the administrator of this system and thus will be responsible for all aspects of its function. The incumbent will be responsible for coordinating laboratory support activities including instrument and equipment maintenance and general laboratory upkeep. The incumbent will provide supplemental support to the department by performing searches of the scientific literature, assisting in the analysis of pharmacokinetic and pharmacodynamic data, and preparing documents associated with the submission of applications to various health authorities

Primary Responsibilities:

1. Develop and qualify immunological-based assays, including enzyme linked immunosorbent assays and electrochemilumunescent assays, in support of nonclinical studies.30%
2. Perform sample analysis in support of nonclinical studies.20%
3. Prepare development/qualification reports and experimental protocols.10%
4. Maintain all necessary laboratory documentation related to the development and qualification of analytical methods.10%
5. Compile scientific data and present experimental results during regular departmental meetings.10%
6. Troubleshoot immunological-based assays.5%
7. Manage the laboratory information management system (LIMS; WatsonTM).5%
8. Perform routine laboratory maintenance on analytical instruments and equipment.5%
9. Ensure that the laboratory is properly stocked with supplies.5%

Training & Type of Experience Required:

1. At least 3-5 years hands-on experience in a bioanalytical laboratory conducting bioanalytical assay development, validation and sample analysis, ideally in an industrial setting. Strong skills in the analysis and interpretation of bioanalytical data, troubleshooting immunological-based assays for detection of large molecules, and preparing method development/qualification protocols and reports are essential.
2. Demonstrated ability to work independently, maintain a strong attention to detail in a fast-paced dynamic environment while having an appreciation for department and corporate timelines and meticulously document all work is required.
3. Extensive experience using of Microsoft Office products, specifically Excel, Powerpoint, and Word, and experience using laboratory information management systems such as WatsonTM LIMS is required.
4. Effective, collaborative interpersonal skills for working in a highly team-oriented environment and with external partners, and exceptional oral and written communication skills communication skills are required.
5. Experience in the safe handling of biological materials is required.
6. Detailed knowledge of Good Laboratory Practices (GLP) and current international regulatory practices and guidances related to bioanalytical sciences in the pharmaceutical/biotechnology industry is desired.
7. A basic understanding of the fundamental principles of pharmacokinetic and pharmacodynamic analysis including a familiarity with the pharmacokinetic modeling software WinNonlin is desired.

Education:
BA/BS: Required- Biological or Chemical Sciences
MA/MS/MBA: Desirable

Call or email:
Steven Karski
Alchemy Scientific, Inc.
51 JFK Parkway
First Floor West
Short Hills, NJ 07078
786-347-6300   
skarski@alchemyscientific.com