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Jan
25
Sandeep Singh Dhillon
Sr. Manager, R&D at Germer International Billings, MT (Monster.com)
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About the Job

Do you love being outdoors and want to get away from the hustle and bustle of a larger town??? If so, you may be interested to know that Germer International has a client located in one of the most beautiful parts of the country where those outdoor recreational activities is available to you right outside your front door. A growing API manufacturing organization located in the Midwest is seeking an expert Process Development Scientist who has industry experience in overseeing a team of R&D Scientists (both Analytical Development and Process Development) to come aboard and join their team. The Sr. Manager, R&D will be involved in the tactical responsibilities of overseeing and developing staff in the lab while working closely with the VP, Product Development in tackling process improvement initiatives and pipeline development.

What does this mean to you????

·An opportunity to lead, mentor, and coach the R&D department consisting of skilled and experienced Scientists in the industry (mainly PhD-level)

·An opportunity to work in a smaller environment that brings a strong family feel and where the team mentality is a strong aspect of the company culture

·Outdoor recreational activities (hiking, horseback riding, camping, fishing, etc…) are right at your fingertips

·Competitive salary, bonus, & relocation assistance provided

Essential Duties and Responsibilities

Provide guidance and oversight to ensure that newly developed manufacturing and product testing processes are state-of-the art, cost-effective, robust, and well-defined.
Through resource and long-term planning, ensure that R&D resources are allocated appropriately to support company goals and long-term strategy, that project deliverables are met, and that development is completed in accordance with ICH Q11 and company policies.
Interact effectively with cross-functional teams, including Project Management, Product Development, QC, QA, Operations and other internal and external development groups.
Conduct patent reviews and work with patent attorneys to ensure that future processes will have freedom to operate and that newly developed IP is appropriately protected.
Conduct feasibility analyses to determine optimal processes for further development.
Write, review, and/or approve scientific documentation, including development reports and regulatory documents in accordance with company policies.
Perform complex laboratory activities including planning and performing experiments, including Design of Experiments, and research for novel processes to produce APIs.
Ensure that analytical test methods used in R&D are scientifically sound and suitable for their intended use throughout the development process and that test methods intended for transfer into QC are able to be validated in accordance with ICH requirements.
Conduct troubleshooting, participate in risk assessments, and provide technical assistance for NPD project teams, Operations, and Quality Control.
Ensure that the R&D laboratory has supplies and organization to perform the assigned work, and is operated in accordance with OSHA, cGMP, DEA, and company policies.

Education/Experience:

·Ph.D. in Chemistry required; with at least 10 years of organic synthesis experience including at least 10 years in a leadership role.

·At least 5 years of experience in analytical method development and validation preferred.

·Research and Development experience in the pharmaceutical industry, specifically in the development of active pharmaceutical ingredients, strongly preferred.

Please apply at https://job-openings.monster.com/Sr-Manager-R-D-Job-Billings-MT-US/11/192379224

Sep
18
Sandeep Singh Dhillon
R&D Reporting Specialist – Monster.com
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Job Summary
Job Status/Type: Full Time Temporary/Contract/Project
Job Category: IT/Software Development
Occupation: General/Other: IT/Software Development
Industry: Staffing/Employment Agencies
Career Level: Experienced (Non-Manager)Reference Code: 102914

Looking for a data orientated candidate that is comfortable with ambiguity and forging ahead to find solutions and drive process.

Responsibilities:

• Contribute to the set-up, maintenance and reporting of data in the HCP Payment and Spend System (HCP PASS). Monitor performance of reporting system and provide recommendations for process or system improvements where appropriate.

• Review contracts and payments to determine what must be reported against a healthcare provider (HCP) and/or teaching institution to comply with internal and government reporting purposes.

• Gather information to ensure that all payment and transfers of value information is captured and coded and provide guidance to influence appropriate decisions regarding all payment and in-kind reporting.

• Compile gathered information and perform data review cross checks to ensure information is accurate, complete and consistent. Identify missing, inaccurate, or incomplete data and liaise with functional areas to obtain updated data. Independently trouble shoot for missing data and documentation needed to complete required reporting. Key areas of collaboration include the following:

? Liaise with Clinical study team leads to gather details and documentation about reportable study supplies and equipment used in R&D clinical studies.

? Liaise with Compliance Operations to understand company reporting needs for R&D meetings. Work with R&D meeting owners to gather information about planned R&D meetings (e.g. investigator meetings, advisory board meetings). Review meeting request documentation for completeness (details about meeting attendees and venue) and coordinate compliance review.
Category:Non-ITcode:new

Job Requirements
Requirements:

• Basic understanding of one or more of the following: clinical study costs, Sunshine Act requirements and reporting, contracts, finance, data management, databases, and compliance

• Experience working in the pharmaceutical industry, especially in research and development

• Knowledge of clinical research and drug development concepts and FDA GCP/ICH regulatory guidelines, and understands clinical terminology

• Intermediate-advanced skills with MS Excel (skilled in using pivot tables and vlookups)

• Bachelor’s degree with 6 years relevant work experience or 4 years relevant work experience with a Master’s degree. 2 years relevant experience required with a Doctorate.

Apply at http://apps.collabera.com/jobs/Post_Details.aspx?qsPostId=102914&src=col_mon

Jul
31
Sandeep Singh Dhillon
GlaxoSmithKline’s new boss streamlines R&D, axes slew of drugs – Reuters
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Ben Hirschler

LONDON (Reuters) – GlaxoSmithKline’s new chief executive announced plans on Wednesday to narrow the focus of the group’s drug research by ditching more than 30 drug projects to improve returns in its core pharmaceuticals business.

Emma Walmsley, who took over in April, said GSK would in future allocate 80 percent of its R&D budget to respiratory and HIV/infectious diseases, along with two other potential areas of oncology and immuno-inflammation.

Thirteen clinical and around 20 pre-clinical programmes will be stopped, partnered or divested, and the group is considering options for its rare diseases unit after a strategic review.

It also plans to stop selling the struggling diabetes drug Tanzeum and end a collaboration with Johnson & Johnson over experimental rheumatoid arthritis drug sirukumab, as well as divesting around 130 old drugs with limited sales.

GSK has lagged behind rivals recently in producing multibillion-dollar blockbusters and has suffered a number of high-profile failures, undermining faith in its R&D skills.

“We’ve been too broadly spread,” Walmsley told reporters, adding that the overhaul would not result in a lower R&D budget because GSK had been investing too little in individual experimental drugs in the past.

Indeed, spending could rise as Walmsley and her team go shopping for promising early-stage experimental drugs to bolster the pipeline in GSK’s priority areas.

The announcement came as Britain’s biggest drugmaker reported a 12 percent rise in adjusted earnings per share in sterling terms to 27.2 pence on sales up 12 percent at 7.32 billion pounds ($9.53 billion).

Analysts, on average, had forecast EPS of 26.2 pence and sales of 7.26 billion pounds, according to Thomson Reuters data.

The group reiterated its outlook for 2020, first given in 2015, forecasting sales growth of low-to-mid single digits and adjusted earnings of mid-to-high single digits on a constant currency basis.

For 2017, it now sees EPS growth of 3-5 percent, against 5-7 percent predicted previously, following investment in a “priority review voucher” to accelerate U.S. approval of a new HIV medicine.

Shares in the group fell 1.3 percent by 1400 GMT, with some investors disappointed that Walmsley had not taken the opportunity to increase long-term financial targets.

Given that she announced an extended cost-cutting programme to deliver an additional 1 billion pounds of annual cost savings by 2020, UBS analyst Michael Leuchten said the cautious approach “suggests tougher underlying trends”.

Following Astrazeneca

Walmsley, who previously headed GSK’s consumer health unit after 17 years working for L’Oreal, is known for her focus on benchmarking business performance and had been expected to revamp pharma R&D.

She had previously said she was considering the divestment of older antibiotics and planning to sell two UK nutritional brands.

Overhauling GSK’s R&D machine is her biggest task, however, and she wants scientific and commercial teams to work closely together to pick winners.

The changes will take time to deliver results but Walmsley does have a window as GSK is not expecting its next wave of new drugs until after 2020. It also has no further major patent expiries until 2026.

To some extent GSK is following in the footsteps of its smaller British rival AstraZeneca, which has divested a large number of non-core drug projects recently. Significantly, former AstraZeneca executive Luke Miels, who joins in September, will be a key lieutenant for Walmsley during the shake-up.

GSK benefited once again in the quarter from a weak pound, after last year’s Brexit vote, as well as strong demand for HIV medicines and the failure, so far, of generic firms to win U.S. approval for copies of its inhaled lung drug Advair.

But HIV competition is set to increase next year and U.S. generics to Advair, which has generated more than $1 billion in annual sales for GSK since 2001, are likely by mid-2018.

The company extended a commitment to pay its current 80 pence per share annual dividend through 2018.

(This version of the story adds dropped first name of CEO in second paragraph)

Additional reporting by Kate Holton, editing by Louise Heavens and Adrian Croft

Jun
6
sandeepsd
MedTech R&D Asia
Upcoming Events & Interviews
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Medtech R&D Asia is a 2 day event being held from 23rd June to the 24th June 2015 at the Suntec Convention Centre in Singapore, Singapore. This event showcases products like medical devices, equipments, various products related to latest developments and many more etc. in the Medical & Pharmaceutical industry. Read more …

Jun
5
sandeepsd
Turing Names Eliseo Salinas President of R&D
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Turing Pharmaceuticals AG announced that life sciences executive and medical researcher Eliseo Oreste Salinas, MD, MSc, has joined the company as president of research and development. Read more …

May
22
ragupathyrenganathan
BIA says action plan could quadruple R&D output by 2025 – Courtesy (PMLive)
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