Saturday, July 7, 2012

[itroundtable] Fwd: Manufacturing, Science and Technology review


Please contact the recruiter directly if  you are interested.


---------- Forwarded message ----------
From: Debra Pohl <>
Date: Thu, Jun 28, 2012 at 5:53 PM
Subject: Manufacturing, Science and Technology review
To: Edith Paul <>


We have just started a search for a Head of Manufacturing Science & Technology within a major pharma company in the NJ/NY area (relocation provided).     This is a newly created position and will start up and manage this group (to 25 employees).   The facility is engaged in high volume solid dosage manufacturing and is expanding.  They are seeking a seasoned individual with strong experience in packaging, engineering and validation within the solid dosage arena.  *Prior experience with start-ups, expansions and bringing in new technologies desired. 

*In addition, we continue our search for a Director Validation within this company requiring strong, broad validation experience within a solid dosage environment and a well developed forward management style and experience.

 I have included below a description of the Head MS&T role (as well as a list of other searches we are working on nationwide) for your review.  Please let me know if you or someone you know may be interested.

PLEASE network this email to others in the industry.  Networking is a powerful tool often the means by which many find their next great career move.  With the current economic state and the volatility of the industry at this time everyone needs to keep an eye out for themselves as well as others.  I thank you for your consideration and support and look forward to hearing back.

** Please feel free to connect with me on Linkedin at

Best wishes,

Debra Pohl
President, Pharmaceutical Recruitment
Alternative Resources Company


Head of Manufacturing Science & Technology

Job Purpose

Make the necessary internal and external benchmark in the scientific environment in order to encourage and expand knowledge.  Promote Excellence in Packaging and Galenic Processes in the plant, as well as new products or technologies, embracing the concept of Quality by Design, DOE and PAT as applicable.  This activity includes adherence to GMP requirements, guidelines, SOPs, as well as respecting the laws, policies and procedures on HSE, with attention to the protection of company assets and compliance with the Code of Conduct.


·       Assure transfers and new product launches are executed to the highest Compliance standards while meeting agreed upon timelines.

·       Responsible for all Process validation activities including preliminary QRA, APR

·       Provide technical support in impact assessments relating to API variant, excipients, equipment change, temperature excursions, etc and assure that the evaluation, selection, and implementation of manufacturing equipment are robust, reliable, and aligned with Company manufacturing strategy.

·       Conduct technical validation studies resulting from major changes

·       Ensure alignment through different areas of expertise within MS&T, promoting synergies to increase knowledge of its members

·       Assure evaluation, selection and implementation of manufacturing and packaging equipment are robust, reliable and aligned with Company manufacturing strategies
•Ensure process robustness using Lean tools

·       Evaluate and recommend future state-of-the-art production systems for PharmOps site

·       Conduct process capability studies of weak point products

·       Support MS&T staff on execution of process improvements, scale-ups, and new package design and justification projects.

·       Provide oversight that process justification batches generate sufficient process knowledge by thoroughly testing critical variables.

·       Coordinate and study weaknesses in the manufacture of products already on the market

·       Provide technical guidance on prioritizing new projects, operational process improvements, equipment re-qualification/routine re-validation, Annual Product Reviews, Analytical Method and product Transfers

·       Assure that technical capability training and guidance are provided on a routine basis to MS&T, PU and Quality members to increase their technical knowledge

·       Develop and provide coaching to the staff of MS&T, identifying their development needs / learning and performance standards including succession planning for the team.

·       Assure trainings where required to MS&T members for assigned new projects or tasks are provided


·       Education:  BS in Science, Pharmacy or Chemical Engineering MS or PhD preferred, or equivalent experience

·       Relevant Experiences

·       Extended technical knowledge in area of own expertise

·       Minimum 5-10 years experience in pharmaceutical formulation, process development, or manufacturing technology (with PhD)

·       Minimum 10+ years experiences in pharmaceutical formulation, process development or manufacturing technology (without PhD)

·       Strong Statistical background, minimum IQP Silver certification (or Green Belt equivalent) statistics level. Experience

·       in DoE and Gage R&R

·       Fundamental understanding of standard pharmaceutical analytical testing



Nationwide listings from ALTERNATIVE RESOURCES COMPANY    

(For detailed job descriptions, please visit our website at


JOB TITLE                                                                                                                                             STATE


ANALYTICAL R&D               

Senior Director, Analytical R&D and QC                                                                               CA



Associate Director, Biostatistics     (2 positions)                                                                    CT

Programmer/Analyst I                                                                                                             NY



Associate Director, Clinical Operations                                                                                  CT

Clinical Operations Manager                                                                                                  NJ

Study Manager                                                                                                                       NJ



Associate Director – Safety Systems                                                                                      NY

Senior Drug Safety Associate                                                                                                 NY

Drug Safety Associate                                                                                                                              CT



Senior Process Engineer                                                                                                          NY



Head of Manufacturing, Science and Technology                                                                 NY



Division Sales Manager                                                                                                          NJ             



Manager, Quality Control                                                                                                       NJ


QUALITY OPERATIONS (QA)               

Manager, Quality Systems                                                                                                      IL

Auditor - Senior Auditor, Quality Systems                                                                            NJ

Quality Specialist III  - GCP Audit                                                                                       CT



Senior Process Engineer                                                                                                          NY



Head of Regulatory Affairs                                                                                                    MN

Director Regulatory Affairs Global Project Lead, Early Development                                 NJ

Associate Director, Global Regulatory Affairs                                                                      MI

Senior Director Regulatory Affairs                                                                                        NJ

Senior Regulatory Affairs Manager                                                                                        NJ



Division Sales Manager                                                                                                          NJ



Director, Validation                                                                                                                NY                             

Senior Process Validation Specialist/Engineer                                                                       NY                                                                                                                       






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Recent Activity:


[CNG] Digest Number 2638

Fri Jul 6, 2012 3:02 pm (PDT) . Posted by: "Tom Bley" tom.bley
Please contact Richard directly. Good luck.

Kind Regards,

Tom Bley, PMP

Project / Program Manager

Cell (973) 919-1252

<> Description: btn_myprofile_160x33

From: [] On
Behalf Of Richard
Sent: Friday, July 06, 2012 11:30 AM
Subject: [BigMoneyJobs] Director, .NET Engineering, NYC - Perm Job

Hi, it me again, just checking to see if you want this Director of .NET
Engineering position in NYC - Perm Job

In a nut shell, client wants to hire a Director of .NET Engineering = you
will manager a 8 person team in NYC and 10 person team in India.
Seeking exp with > ASP.NET, C#, WCF, SQL Server

Perm Job - about $160,000 base + Bonus
Location - NYC, NY

This a huge company - NOT Financial - on-line/Media firm.

SEND resume directly to me -

Read below.....

Director of .NET Engineering position in NYC - Perm Job

Manage team of .NET Developers with Mobile exp Lead for its high-performing
development team to work on cutting-edge .Net technologies.

Responsibility of the Lead will be to work in a team environment and engage
in full software development life cycle, including designing, developing and

All profiles submitted should have technical hands-on experience in DOTNET
and RDBMS.

BIG PLUS > past work experience on Retail (Customer Facing) web sites.

. Lead teams of software engineers (onsite and offsite) providing technical
leadership and mentoring.
. Lead projects from start (requirements) to finish (implementation).
. Analyze, design, estimate for all application tiers.
. Code, test, debug, and document.
. Revise and update programs and processes and create documentation as
. Software Development Processes, and company standards and practices.
. Able to highlight and communicate project status, tasks, milestones,
. Able to prepare and present project and technology documents to group.

. Languages and frameworks: C#, VB.Net, ASP.Net, JavaScript, XML (schemas,
documents, transformations), Strong RDBMS and Database experience required.

Oracle is a big plus.

. Expert knowledge of the .Net framework and object oriented design and
programming concepts.
. Proficiency in technical documentation using UML.
. Solid front-end development capabilities (ASP.NET to Middleware) and/or
back-end development capabilities (Middleware to Relational databases)
. Experience with MS Visual Studio, Oracle (TOAD), XML Spy, Source Control
Systems, NAnt, NUnit.
. Experience in Web Services and SOA.
. Ability to interact with Business Owners to gather and document project

. Bachelor's degree with coding experience delivering web based

Live long and prosper my friend...~

Richard Smith
Director, Talent Acquisition
InRhythmT | Accelerating Market Value <>
O: 201.706.7005

Fri Jul 6, 2012 3:02 pm (PDT) . Posted by: "Eric Nilsson" norsemantechnology
<> Tom Searcy

7 Things You're Doing Wrong on LinkedIn

Most professionals use the social networking site in some capacity--but one
expert says they're making a lot of mistakes.

Today, LinkedIn is the No. 1 social media platform for professionals.
Estimates of professional participation in LinkedIn are as high as 83%.

But when I talked to one of my friends--social media expert Alexandra Gibson
from OttoPilot Media--she told me that she sees too many professionals
making a lot of mistakes. Here are the seven she sees most often.

See it all here:

Fri Jul 6, 2012 3:02 pm (PDT) . Posted by: "Gary Wright - Wright Associates" wrightassociates
Please feel free to refer this position to other groups and people you know.

Still Searching for Strong Candidates - 07-06-2012 - 2 roles still open.

Key to this role is recent experience out of a software firm managing
multiple enterprise wide application centric implementations.

Position Title - WRPPSPM052012

Sr. Project Manager's - PMP Certification - Software Firm Background - Any
Location East/MW/SE - Excellent Package

Excellent Compensation Package - Base + Bonus + Comprehensive Benefits (100%

No Relocation or Sponsorship


2 Roles - Can be located anywhere in the East/Midwest.


Highly successful, highly profitable, very fast growing (50%+), private
software firm, focused on delivering a fully integrated suite of
asset-centric accounting, tax, budgeting, regulatory, compliance/risk
management and analytics software solutions for asset intensive clients.
Great firm with an excellent history of growth - Lots of Upside - Excellent
Compensation Package - Base + Bonus + Comprehensive Benefits (100% company
paid) - Join a team oriented, collaborative, results focused environment and
become part of an elite organization with great growth possibilities.

Position Responsibilities - Summary:

PM's will be responsible for managing the implementation/delivery of the
firm's software at client sites - This role will manage the client
relationship, the budgets/schedules, project personnel, and the successful
delivery of the project. Additionally, this person will help define/refine
the firm's implementation methodology, and act as a coach/mentor/trainer to
others in the organization on appropriate project management &
implementation methods.
Software is currently installed on premise and project length ranges from
6-9 months for average sized projects, with 1-3 people assigned, and 12+
months for large sized projects, with 4-6 people assigned.

PM will be responsible for managing multiple projects depending on size,
scale and scope of efforts.
Travel is expected to be in the 50%+ area, all of US + Some Canadian - Home
Office Based roles with expenses fully paid.

The PM reports into the Professional Services Organization.

Required Skills and Competencies:

· PMP Certification Required
· 5-10 years of PM experience implementing large enterprise wide
software solutions.
· Previous experience working for a software vendor, implementing
· Superior communication, presentation, and customer relationship
· Experienced with formal implementation methodologies.
· Experience with business process consulting and workflow analysis
· Appropriate 4 year degree or relevant related experience
· For the Lead Role, appropriate experience managing other PM's or
running a PM Practice


· Previous experience managing the implementation of large
enterprise wide Financial, ERP, EAM, CRM or related systems.
· Previous Industry experience with one of the following; Utilities,
Oil & Gas Exploration, Mining, Transportation, or Telecomm.

As a condition of hire, a full background check and drug tests are required.

Contact Information - (Resumes in Word Format to);

Gary Wright - President - Wright Associates - High Technology Recruiting

Phone - (508) 761-6354 - Email - - WEB
Site -

Fri Jul 6, 2012 5:33 pm (PDT) . Posted by: "Eric Nilsson" norsemantechnology
Urgent Job Opportunity with Fortune 100 DIRECT client: Technical Writer -
III in PISCATAWAY, NJ (Pharma\ Healthcare experience required). Send your
updated profiles to: ASAP


Our client, is currently recruiting for a Technical Writer with
documentation experience to write standard operating procedures, work
instructions and process narratives to support the development of
standardizing operational standards and procedure for the Information
Technology Division.
It provides account management and customer support services to key health
care customers, including hospital systems and group purchasing
organizations, leading health plans, pharmacy benefit managers, and
government health care institutions. The company also provides contract
management, logistics and supply chain functions.

Responsibilities include:

. Preparing new and revised technical information for use in information
systems standards documentation, operations
procedures and technical administration process maps. Procedures will
represent information on how to operate and maintain Information Technology
(IT) applications/processes. Work instructions will be a detail document of
the Standard Operating Procedure (SOP). There will be one SOP per
application/process and many work instructions per SOP.
. Detailed subjects that may be addressed by assignment are: 1)
documentation related to systems administration
standards; 2) change control standards and procedures for business
applications and network platforms; 3) standards and procedures related to
information systems security; 4) data management standards; and 5) software
deployment and administration standards and procedures.
. Required to convert legacy documentation SOP/Work Instructions (WI) to a
form that is consistent with current SOP policies.
. May be required to develop new information systems procedures to address
current business approach.
. Work will be performed under the general supervision of the Information
Technology Compliance and Security Manager.
. The contractor's work will require consultation with IT managers,
applications developers, and systems administrators to gain a full
understanding of the technical business operations and requirements that are
subject to document development.

Qualifications include:

. A Bachelor's Degree is required.
. Highly motivated individual that will be able to write new operating
procedures based on Subject Matter Expert (SME) knowledge/documentation
including process flow maps, requirements descriptions and existing
procedure documents where applicable.
. Minimum of 5 - 7 years experience in technical SOP writing experience with
knowledge of Computer System Validation (CSV) and Sarbanes-Oxley (SOX).
. Demonstrate an understanding of IT business operations.
. Demonstrate experience developing technical documentation for IT
. Must be proficient with a personal computer (MS Windows operating system),
and various software including spreadsheet, word processing, illustration,
and visio [sic] programs.
. Strong writing and communication skills are required.
. Self motivated and excels independently in a team environment.
. Ability to collaborate with subject matter experts in a project based
. Flexibility is a must.

LinkedIn ad appears at:
31413474&gid=112571> &discussionID=131413474&gid=112571

Posted by Faraz Husain, Executive- Resourcing at Pyramid Consulting

Fri Jul 6, 2012 5:33 pm (PDT) . Posted by: "Eric Nilsson" norsemantechnology
Need a Technical Writer in Raritan, NJ, USA area

Qualifications include:
. A Bachelor's Degree is required.
. Highly motivated individual that will be able to write new operating
procedures based on Subject Matter Expert (SME) knowledge/documentation
including process flow maps, requirements descriptions and existing
procedure documents where applicable.
. Minimum of 5 - 7 years experience in technical SOP writing experience with
knowledge of Computer System Validation (CSV) and Sarbanes-Oxley (SOX).
. Demonstrate an understanding of IT business operations.
. Demonstrate experience developing technical documentation for IT
. Must be proficient with a personal computer (MS Windows operating system),
and various software including spreadsheet, word processing, illustration,
and visio [sic] programs.
. Strong writing and communication skills are required.
. Self motivated and excels independently in a team environment.
. Ability to collaborate with subject matter experts in a project based
. Flexibility is a must

Jitendra Kushwah
cyber Think, Inc.
1125 US Hwy 22, Suite 1
Bridgewater, NJ 08807
Phone: 732-481-4174 Ext 566 I 877-223-7153 Ext 566
Fax: (908) 429-8004
Website: <>

Posted on LinkedIn at:
31142053&gid=112571> &discussionID=131142053&gid=112571

Posted by Jitendra Kushwah, Technical Recruiter

Sat Jul 7, 2012 8:19 am (PDT) . Posted by: "Alex Freund" alexfreund10
I am offering again a FREE community service at the Trinity Church of
Princeton in the form of a "Resume Tune-up
Workshop". Participants will walk away with knowledge about subjects such
as; the resume appearance, how to avoid common resume mistakes, what
constitutes an effective resume, the effective way of using keywords in
addition to many pertinent tips for resume improvements. Who is this
workshop for? It is mostly recommended for people who are currently in
transition or others who are considering changing jobs.

Where: Trinity Church - 33 Mercer Street Princeton, NJ 08540

When: TUESDAY, July 31, 2012 from 10:00 am to approx. 1:00 pm

How to sign up: Click on this URL: to provide
your contact information and click on "Submit". Once received you will get
further instructions.

The church is limiting attendance to a maximum of 80 people. It is on first
come first served basis.

To learn more about my background visit
<> or on
mobile, view my LinkedIn Profile <>
and read my blogs at

Alex Freund


Email me at: <>

Visit my website: <>

Read my blogs at: <>

Connect with me on LinkedIn: <>

Follow me on Twitter: <>

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Join the CNG LinkedIn Group.
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